title: Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. A randomised controlled trial of total hip arthroplasty versus resurfacing arthroplasty in the treatment of young patients with arthritis of the hip joint Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial. Ceramic-on-ceramic total hip arthroplasty: update. Wear rate of highly cross-linked polyethylene in total hip arthroplasty. A randomized controlled trial. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials A prospective, randomized study of cross-linked and non-cross-linked polyethylene for total hip arthroplasty at 10-year follow-up. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials Validity of the MACTAR questionnaire as a functional index in a rheumatoid arthritis clinical trial. The McMaster Toronto Arthritis. No differences in outcomes between cemented and uncemented acetabular components after 12–14 years: results from a randomized controlled trial comparing Duraloc with Charnley cups Cemented versus cementless stems: a verdict is in. Pitfalls in randomized surgical trials. Prospective, randomized comparison of cobalt-chrome and titanium trilock femoral stems. Comparison of surgical outcomes and implant wear between ceramic-ceramic and ceramic-polyethylene articulations in total hip arthroplasty. Alumina ceramic bearings for total hip arthroplasty. The Charnley stem: clinical, radiological and survival data after 11-14 years. Wear and migration of highly cross-linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: a randomized radiostereometric study of 150 patients. Alumina Ceramic Bearings for Total Hip Arthroplasty: Five-year Results of a Prospective Randomized Study Comparison of total hip replacement with and without cement in patients younger than 50 years of age: the results at 18 years. What Works Best, a Cemented or Cementless Primary Total Hip Arthroplasty?: Minimum 17-year Followup of a Randomized Controlled Trial Osteoarthritis Index delivered by mobile phone (m-WOMAC) is valid, reliable, and responsive. Comparison of total hip arthroplasty performed with and without cement: a randomized trial. A concise follow-up, at twenty years, of previous reports. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Comparison of Total Hip Arthroplasty Performed with and without Cement: A Randomized Trial Questionnaire on the perceptions of patients about total hip replacement. Comparison of mid-term clinical outcomes after primary total hip arthroplasty with Oxinium vs cobalt chrome femoral heads. Challenges in evaluating surgical innovation Cemented polyethylene and cementless porous-coated acetabular components have similar outcomes at a mean of seven years after total hip replacement: a prospective randomised study.
abstract: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care CONTEXT R and omized controlled trials have been developed essentially in the context of pharmacological treatments ( ie , oral drugs ; intra-articular injection ; and topical , intramuscular , and intravenous treatments ) , but assessment of the effectiveness of nonpharmacological treatments ( ie , surgery , arthroscopy , joint lavage , rehabilitation , acupuncture , and education ) presents specific issues . OBJECTIVES To compare the quality of articles of  nonpharmacological and pharmacological treatments of hip and knee osteoarthritis and to identify specific method ological issues related to assessment of nonpharmacological treatments . DESIGN AND SETTING We search ed MEDLINE and the Cochrane Central Register of Controlled Trials for articles of r and omized controlled trials published between January 1 , 1992 , and February 28 , 2002 , in 28 general medical and specialty journals with high impact factors and assessing nonpharmacological and pharmacological treatments in patients with hip or knee osteoarthritis . MAIN OUTCOME MEASURES The quality of the methods reported in the selected articles was assessed by 2 independent review ers using the Jadad scale , the Delphi list , and guidelines found in the Users ' Guides to the Medical Literature . Investigators also used a checklist of items developed by the authors to analyze study characteristics . RESULTS A total of 110 articles were included in the analysis ; 50 ( 45.5 % ) assessed nonpharmacological treatments and 60 ( 54.5 % ) assessed pharmacological treatments . Reports of nonpharmacological treatments had a lower global quality score than did reports of pharmacological treatments as measured by the Jadad scale ( mean [ SD ] score , 1.4 [ 1.3 ] vs 3.0 [ 1.3 ] ) and the Delphi list ( mean [ SD ] score , 5.2 [ 1.5 ] vs 7.5 [ 1.1 ] ) . Lack of reporting adequate r and om sequence generation and intention-to-treat analyses were found in both nonpharmacological and pharmacological articles . Nonpharmacological treatments were less often compared with a placebo than were pharmacological treatments ( 28.0 % of articles vs 71.7 % ) . Compared with pharmacological articles , nonpharmacological articles less often described blinding of patients ( 26.0 % vs 96.7 % ) , care providers ( 6.0 % vs 81.7 % ) , and outcome assessors ( 68.0 % vs 98.3 % ) . Care providers ' skill levels could influence treatment effect in 84.0 % of nonpharmacological articles vs 23.3 % of pharmacological articles . CONCLUSIONS In this analysis of reports of hip and knee osteoarthritis therapy , nonpharmacological articles scored lower than pharmacological articles in terms of quality . Assessment s of nonpharmacological treatments must take into consideration additional method ological issues BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments Background Hip replacement ( arthroplasty ) surgery is a highly successful treatment for patients with severe symptomatic arthritis of the hip joint . For older patients , several design s of Total Hip Arthroplasty have shown excellent results in terms of both function and value for money . However , in younger more active patients , there is approximately a 50 % failure rate at 25 years for traditional implants . Hip resurfacing is a relatively new arthroplasty technique . In a recent review of the literature on resurfacing arthroplasty it was concluded that the short-term functional results appear promising but some potential early disadvantages were identified , including the risk of femoral neck fracture and collapse of the head of the femur . The aim of the current study is to assess whether there is a difference in functional hip scores at one year post-operation between Total Hip Arthroplasty and Resurfacing Arthroplasty . Secondary aims include assessment of complication rates for both procedures as well cost effectiveness . Methods / design All patients medically fit for surgery and deemed suitable for a resurfacing arthroplasty are eligible to take part in this study . A r and omisation sequence will be produced and administered independently . After consenting , all patients will be clinical ly review ed and hip function , quality of life and physical activity level will be assessed through question naires . The allocated surgery will then be performed with the preferred technique of the surgeon . Six weeks post-operation hip function will be assessed and complications recorded . Three , six and 12 months post-operation hip function , quality of life and physical activity level will be assessed . Additional information about patients ' out-of-pocket expenses will also be collected . Trial registration Current Controlled Trials IS RCT N33354155UKCLRN portfolio ID BACKGROUND The use of larger femoral heads has been proposed to reduce the risk of dislocation after total hip arthroplasty , but there is a lack of evidence to support this proposal . The aim of this multicenter r and omized controlled trial was to determine whether the incidence of dislocation one year after total hip arthroplasty is significantly lower in association with the use of a 36-mm femoral head articulation as compared with a 28-mm articulation . METHODS Six hundred and forty-four middle-aged and elderly patients undergoing primary or revision arthroplasty were r and omized intraoperatively to receive either a 36 or 28-mm metal femoral head on highly cross-linked polyethylene .  Patients who were at high risk of dislocation ( including those with dementia and neuromuscular disease ) and those undergoing revision for the treatment of recurrent hip dislocation or infection were excluded . Patients were stratified according to other potential risk factors for dislocation , including diagnosis and age . Diagnosis of hip dislocation required confirmation by a physician and radiographic evidence of a dislocation . RESULTS Overall , at one year of follow-up , hips with a 36-mm femoral head articulation had a significantly lower incidence of dislocation than did those with a 28-mm articulation ( 1.3 % [ four of 299 ] compared with 5.4 % [ seventeen of 316 ] ; difference , 4.1 % [ 95 % confidence interval , 1.2 % to 7.2 % ] ) when controlling for the type of procedure ( primary or revision ) ( p = 0.012 ) . The incidence of dislocation following primary arthroplasty was also significantly lower for hips with a 36-mm femoral head articulation than for those with a 28-mm articulation ( 0.8 % [ two of 258 ] compared with 4.4 % [ twelve of 275 ] ; difference , 3.6 % [ 95 % confidence interval , 0.9 % to 6.8 % ] ) ( p = 0.024 ) . The incidence of dislocation following revision arthroplasty was 4.9 % ( two of forty-one ) for hips with a 36-mm articulation and 12.2 % ( five of forty-one ) for hips with a 28-mm articulation ; this difference was not significant with the relatively small sample size of the revision group ( difference , 7.3 % [ 95 % confidence interval , -5.9 % to 21.1 % ] ) ( p = 0.273 ) . CONCLUSIONS Compared with a 28-mm femoral head articulation , a larger 36-mm articulation result ed in a significantly decreased incidence of dislocation in the first year following primary total hip arthroplasty . However , before a 36-mm metal-on-highly cross-linked polyethylene articulation is widely recommended , the incidence of late dislocation , wear , periprosthetic osteolysis , and liner fracture should be established This prospect i ve , r and omized , multicenter study of alumina ceramic-on-alumina ceramic bearing couples includes 452 patients ( 475 hips ) . Their average age was 53 years with approximately two thirds men and 82 % with osteoarthritis . At an average 8-year follow-up , clinical results were excellent and cortical erosions significantly less than in the conventional polyethylene-on-metal bearing group . Nine hips have undergone revision of one or both components for any reason . Of the 380 ceramic liners , 2 ( 0.5 % ) have fractured requiring reoperation , and 3 ( 0.8 % ) ceramic patients reported a transient squeaking sound , one of which had a head and liner change due to groin pain secondary to psoas tendinitis at 5 years . With no revisions for aseptic loosening and minimal cortical erosions , alumina-ceramic bearing couples are performing in a manner superior to the polyethylene-on-metal bearing in this young , active patient population BACKGROUND Highly cross-linked polyethylene was introduced for clinical use in total hip arthroplasty with the expectation that it would exhibit less wear when compared with conventional polyethylene . The purpose of this study was to report the clinical and radiographic results , after a minimum of five years of follow-up , of a r and omized , blinded , controlled trial comparing a conventional polyethylene with a first-generation highly cross-linked polyethylene . METHODS One hundred patients were enrolled in a prospect i ve , r and omized controlled study comparing highly cross-linked and conventional polyethylene acetabular liners in total hip arthroplasty . Fifty patients were in each group . At the time of follow-up , clinical outcomes were assessed and steady-state femoral head penetration rates ( after bedding-in ) for each patient were calculated with use of a vali date d radiographic technique . In addition , a statistical comparison of polyethylene wear between groups was performed with use of generalized estimating equations . RESULTS At a mean of 6.8 years postoperatively , there were no differences between the two polyethylene groups with regard to the Harris hip score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , or Short Form-12 ( SF-12 ) score . The mean femoral head penetration rate in the first through fifth years was found to be significantly lower in the group treated with the highly cross-linked polyethylene ( 0.003 mm/yr [ 95 % confidence interval , + /-0.027 ] ) than it was in the group treated with conventional polyethylene ( 0.051 mm/yr [ 95 % confidence interval , + /-0.022 ] ) ( p=0.006 ) . Men treated with a conventional polyethylene liner had a significantly higher ( p < or=0.012 ) femoral head penetration rate ( 0.081 mm/yr [ 95 % confidence interval , + /-0.065 ] ) than both men and women with a highly cross-linked liner ( -0.013 mm/yr [ 95 % confidence interval , + /-0.074 ] and 0.009 mm/yr [ 95 % confidence interval , + /-0.028 ] , respectively ) . The general estimating equations demonstrated that the group with a highly cross-linked polyethylene liner had a significantly lower femoral head penetration rate than the group with a conventional polyethylene liner ( p=0.025 ) , and a significantly higher femoral head penetration rate was demonstrated in men with a conventional polyethylene  liner when compared with both men and women with a highly cross-linked liner ( p=0.003 ) . CONCLUSIONS At a minimum of five years postoperatively , the steady-state femoral head penetration rate associated with this first-generation highly cross-linked polyethylene liner was significantly lower than that associated with a conventional polyethylene liner . Long-term follow-up is required to demonstrate the clinical benefit of this new material Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more In 1999 , our institution initiated a prospect i ve study to compare the outcome of total hip arthroplasty patients r and omized to either non-cross-linked liners or polyethylene liners that were cross-linked with 5.0 Mrad of gamma-irradiation and heat treated to eliminate free radicals . Among 230 r and omized THAs , 13 have had reoperations , and 31 patients with 32 THAs died with less than 9-year follow-up . Follow-up for the remaining 185 THAs averaged 10.0 ± 1.8 years . There have been 9 wear-related liner exchanges among the non-cross-linked group and none among the cross-linked group . Using revision for wear-related complications as an endpoint , survivorship at 10-years was 94.7 ± 4.6 % for non-cross-linked and 100 % for cross-linked ( P = .003 ) . Among unrevised hips , the mean linear wear rate was 0.22 mm/yr for non-cross-linked and 0.04 mm/yr for cross-linked ( P < .001 ) . The incidence of clinical ly important osteolysis with an area of at least 1.5 square centimeters among unrevised hips was 22 % for non-cross-linked and 0 % for cross-linked ( P < .001 ) The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . OBJECTIVES The McMaster Toronto Arthritis patient preference question naire ( MACTAR ) is a functional index that measures change in impaired activities selected by each patient in a baseline interview , and change in rheumatoid arthritis ( RA ) disease activity . In addition , it contains questions on the state of physical , social and emotional function and overall health , and their relation to RA . We evaluated MACTAR 's feasibility and validity ( content validity , construct validity , and responsiveness ) . METHODS A r and omized trial of combined treatment in 155 patients with early RA ; patients ' mean age at baseline was 50 years and median disease duration since diagnosis was 4 months . RESULTS Feasibility : MACTAR requires trained interviewers . In the trial , interviews took about 15 min . In longer term followup , activities selected at baseline may become less relevant as the pattern of disability changes . Followup from 153 patients ( 99 % ) was available . At least 5 impaired activities were identified and ranked by 147 patients ( 95 % ) ; interviewers could follow 99 % of these . The scoring system proved complex and required amendments . Content validity : Although its main focus is physical function , the MACTAR also contains generic questions ; 75 % of the patients named at least one impaired activity from the category " mobility . " Only 48 % were covered by Health Assessment Question naire ( HAQ ) items . Construct validity : MACTAR scores correlate highly with other functional indices and with measures of disease activity . Responsiveness : At 16 weeks the st and ardized response mean for the total MACTAR score in the combined-treatment group was excellent , at 2.2 . Items that directly address change were even more responsive . CONCLUSION The MACTAR interview is a valid and highly responsive instrument to assess change in functional ability of patients with early RA with active disease . It provides insight into problems -- mainly of physical function -- that really matter to patients . For st and ard clinical trials and clinical care , feasibility of the MACTAR is limited and the simpler HAQ remains the instrument of choice Background Even though there are multiple studies documenting the outcome of the Charnley low-friction arthroplasty as well as abundant studies on uncemented arthroplasties , there is a dearth of comparative studies of the uncemented acetabular component and a cemented component . In this study we aim ed to document the long-term clinical and radiographic outcome as well as component survival in a r and omized controlled trial . Material s and methods Two hundred fifteen patients ( 240 hips ) were r and omly allocated to receive a cemented Charnley cup or uncemented Duraloc 1200 cup . All patients received cemented Charnley stems and were evaluated clinical ly and radiographically after 6 months , and 2 , 5 , and 10 years . Results Harris Hip Scores improved from 48.3 [ 95 % confidence interval ( CI ) 45.0–51.6 ] to 90.2 [ 95 % CI 87.9–92.6 ] in the Charnley group and from 49.3 [ 95 % CI 86.9–91.3 ] in the Duraloc group at 6 months . After 10 years , the Charnley group ’s Harris Hip Score was 89.8 [ 95 % confidence interval ( CI ) 87.0–92.6 ] , and the Duraloc group ’s score was 87.3 ( 95 % CI 84.1–90.6 ) . In the radiographic analysis after 10 years , there was no statistical difference in the prevalence of radiographic signs of loosening . Nine cups were revised in the Charnley group , and five cups were removed in the Duraloc group . The difference was not statistically significant . There was no statistical difference between the cups when aseptic loosening was the end-point , nor in survival analyses . Conclusions There is no statistically significant difference in clinical or radiological outcome between the Charnley cup and the Duraloc after 10 years , and no difference in implant survival after 12–14 years . The uncemented Duraloc cup is as good as the cemented Charnley cup after 10 years The purpose of this r and omized clinical trial was to compare the > 20-year outcomes of cemented ( n=124 ) versus cementless ( n=126 )  total hip replacements ( THRs ) in patients with end-stage , unilateral hip osteoarthritis . At 20 years , 168 patients ( 67 % ) were available for follow-up , 78 ( 31 % ) had died , and 4 ( 2 % ) were lost . A power analysis was performed to determine the number of patients needed in each study cohort . Patients were assessed pre- and postoperatively by vali date d disease-specific Western Ontario McMaster Osteoarthritis Score , patient-specific McMaster Arthritis Score , global health ( sickness impact profile ) , functional capacity ( 6-minute walk ) , and cost utility ( cost-to- quality adjusted life years ) . Patients were followed every 2 years clinical ly and radiographically . The cementless THR outperformed its cemented counterpart in terms of overall ( P=.01 ) , socket ( P=.009 ) , and stem ( P<.0001 ) Kaplan-Meier survivorships . Patients younger than 65 years had significantly poorer cemented and cementless socket survivorships , and male sex adversely affected cementless socket survivorship . The cementless tapered stem had 100 % survivorship with aseptic loosening as the endpoint at 20 years . Although this study has demonstrated the superiority of the cementless THR over its cemented counterpart , care must be taken in generalizing these results to other cemented and cementless THRs Special problems may arise when the principles of the r and omized trial are used to compare operative methods . In the trial design that is used at present , each surgeon performs the operatons to be compared in a r and om order . A prerequisite for a trial so design ed to result in a fair comparison is that the participating surgeons are equally conversant with both techniques . If they are not , the design may imply systematic bias in favor of operations that are in wide use and bias in favor of technically simple procedures . An alternative to this design is given . Reports on trials should contain information about pretrial routine and level of training of participants The purpose of this article was to demonstrate the efficacy of a cementless , flat , tapered wedge femoral stem and compare cobalt-chrome and titanium femoral stems with this design . Three hundred ninety femoral stems observed for a mean of 4.7 years ( 2.0 - 8.9 years ) were prospect ively evaluated with clinical and radiographic follow-up . Hips were stratified by Dorr classification , bone stock ( femoral index ) , size of implant used , and material of femoral implant . Survivorship of the femoral stem at 8.9 years was 99.8 % with no significant difference between cohorts . Thigh pain ( 4.9 % ) was more common with cobalt-chrome femoral stems ( 6.5 % ) than titanium femoral stems ( 3.1 % ) . The flat , tapered wedge femoral stem design provides excellent femoral reconstruction in total hip arthroplasty . On the basis of this study , we use titanium femoral stems The results of a prospect i ve multicenter trial comparing 357 hips r and omized to total hip arthroplasty with either ceramic-ceramic or ceramic-polyethylene couplings  are presented . No statistically significant difference in clinical outcomes scores between the ceramic-ceramic and ceramic-polyethylene groups was observed at any time interval . The mean linear rate was statistically lower ( P < .001 ) in the ceramic-ceramic group ( 30.5 μm/year ) when compared with the ceramic-polyethylene group ( 218.2 μm/year ) . The rates of ceramic implant fracture ( 2.6 % ) and audible component-related noise ( 3.1 % ) were statistically higher in the ceramic-ceramic group when compared with the ceramic-polyethylene group ( P < .05 ) . Lastly , there was no statistically significant difference in the dislocation or revision rate between the groups at the time of last clinical follow-up This article presents an experience with alumina ceramic bearings involving the use of improved ceramic material s as well as new design considerations . The alumina-alumina ceramic hard bearing is a safe option for the younger , more active patient BACKGROUND The Charnley stem provides good outcome for 10 years , but several studies find deteriorating results thereafter . However , study population s , techniques and data analysis vary widely . We have studied 240 Charnley stems in a homogeneous group of patients providing clinical , radiological and survival data after 11 - 14 years . HYPOTHESIS The clinical and radiological outcome of the Charnley stem is not as good than previously thought . PATIENTS AND METHODS Five surgeons implanted 240 femoral stems in a community hospital in Norway using antibiotic impregnated cement and third generation cementing techniques . The Charnley stems were implanted with a Charnley cup in 120 cases and an uncemented hemispherical cup ( Duraloc ) in 120 cases . The mean age of the patients was 65.5 years and the mean Body Mass Index ( BMI ) was 26.8 . All patients received low molecular weight heparin and antibiotic prophylaxis . Patients were assessed after 10 years by means of Harris Hip Score ( HHS ) and radiographic evaluation . Implant survival studies were performed after 11 - 14 years . RESULTS One hundred and fifty-eight patients were available for clinical and radiographic evaluation after 10 years . HHS improved from 48.4 ( 95 % CI : 46.6 - 50,2 ) preoperatively to 87.9 ( 95%CI : 86.6 - 89.3 ) after 6 months and 87.6 ( 95 % CI : 85.3 - 89.8 ) at 10 years . Thirty-one stems had been revised , the reasons for revision were loosening ( 21 ) , infection ( five ) , instability ( four ) and late perisprosthetic fracture ( one ) . Forty-one stems had one or more signs of loosening . Stem survival was 83.6 % using any revisions as end point , and mean estimated stem survival was 12.7 years ( 12.2 - 13.3 years ) . DISCUSSION Other studies report survival at mid-term from 83 - 96 % . Our results are in the low-end . Even though our rate of infection was high ( 2 % ) , the main cause of the poor results is aseptic loosening . We do not know the reason for this high-rate of loosening . As we believe that our technique is adequate and patient population average , we suspect that this rate of loosening is a characteristic of the implant . Results from this prospect i ve cohort study add to the evidence that the Charnley stem should not be used hip arthroplasty unless patient life expectancy is less than 10 years This r and omized study was performed to compare wear and migration of five different cemented total hip joint articulations in 150 patients . The patients received either a Charnley femoral stem with a 22.2  mm head  or a Spectron EF femoral stem with a 28 mm head . The Charnley articulated with a γ-sterilized Charnley Ogee acetabular cup . The Spectron EF was used with either EtO-sterilized non-cross-linked polyethylene ( Reflection All-Poly ) or highly cross-linked ( Reflection All-Poly XLPE ) cups , combined with either cobalt chrome ( CoCr ) or Oxinium femoral heads . The patients were followed with repeated RSA measurements for 2 years . After 2 years , the EtO-sterilized non-cross-linked Reflection All-Poly cups had more than four times higher proximal penetration than its highly cross-linked counterpart . Use of Oxinium femoral heads did not affect penetration at 2 years compared to heads made of CoCr . Further follow-up is needed to evaluate the benefits , if any , of Oxinium femoral heads in the clinical setting . The Charnley Ogee was not outperformed by the more recently introduced implants in our study . We conclude that this prostheses still represents a st and ard against which new implants can be measured Three hundred twenty-eight ceramic bearings were implanted by six surgeons in 316 patients as a part of a prospect i ve r and omized US Investigational Device Exemption study comparing alumina ceramic bearings with cobalt chrome-on-polyethylene bearings . There was no difference between the control metal-on-polyethylene and the alumina bearing couple patient cohorts regarding demographics or clinical scores through 7 years . Revision for any reason occurred in 2.7 % of the patients with alumina bearings and 7.5 % of the control patients with polyethylene bearings .  Osteolysis was found in 1.4 % of the patients with alumina bearings and in 14.0 % of the control patients . At an average followup of 5.0 years ( range , 1 - 86 months ) no ceramic fractures or ceramic bearing failures have occurred . Results of this study suggest that alumina ceramics  perform as well as the metal-on-polyethylene in clinical scores , but the patients with ceramic bearings had fewer revisions and less osteolysis . These results lead us to think that this new alumina ceramic bearing provides a safe option for younger and more active patients . Level of Evidence : Therapeutic study , Level I-1b ( r and omized controlled trial , no significant difference , but narrow confidence intervals ) . See the Guidelines for Authors for a complete description of levels of evidence There have been comparatively few studies of the incidence of osteolysis and the survival of hybrid and cementless total hip replacements ( THRs ) in patients younger than 50 years of age . We prospect ively review ed 78 patients ( 109 hips ) with a hybrid THR having a mean age of 43.4 years ( 21 to 50 ) and 79 patients ( 110 hips ) with a cementless THR with a mean age of 46.8 years ( 21 to 49 ) . The patients were evaluated clinical ly using the Harris hip score , the Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis score and the University of California , Los Angeles ( UCLA ) activity score .  Radiographs and CT scans were assessed for loosening and osteolysis . The mean follow-up was for 18.4 years ( 16 to 19 ) in both groups . The mean post-operative Harris hip scores ( 91 points versus 90 points ) , the mean WOMAC scores ( 11 points versus 13 points ) and UCLA activity scores ( 6.9 points versus 7.1 points ) were similar in both groups . The revision rates of the acetabular component ( 13 % versus 16 % ) and the femoral component ( 3 % versus 4 % ) , and the survival of the acetabular component ( 87 % versus 84 % ) and the femoral component ( 97 % versus 96 % ) were similar in both groups . Although the long-term fixation of the acetabular metallic shell and the cemented and cementless femoral components was outst and ing , wear and peri-acetabular osteolysis constitute the major challenges of THR in young patients Background  Total hip arthroplasty ( THA )  has been associated with high survival rates , but debate remains concerning the best fixation mode of THA . Questions / purpose sWe conducted a r and omized controlled trial ( RCT ) with 250 patients with a mean age of 64 years between October 1987 and January 1992 to compare the results of cementless and cemented fixation . Patients and Methods Patients were evaluated for revision of either of the components . One hundred twenty-seven patients had died ( 51 % ) and 12 ( 4.8 % ) were lost to followup . The minimum 17-year followup data ( mean , 20 years ; range , 17–21 years ) for 52 patients of the cementless group and 41 patients of the cemented group were available for evaluation . Results Kaplan-Meier survivorship analysis at 20 years revealed lower survival rates of cemented compared with cementless THA . The cementless tapered stem was associated with a survivorship of 99 % . Age younger than 65 years and male gender were predictors of revision surgery . Conclusions The efficacy of future RCTs can be enhanced by r and omizing patients in specific patient cohorts stratified to age and gender in multicenter RCTs . Including only younger patients might improve the efficacy of a future RCT with smaller sample sizes being required . A minimum 10-year followup should be anticipated , but this can be expected to be longer if the difference in level of quality between the compared implants is smaller . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence OBJECTIVES To evaluate the validity , reliability , responsiveness , and mode preference of electronic data capture ( EDC ) using the Western Ontario and McMaster ( WOMAC ) numerical rating scale ( NRS ) 3.1 Osteoarthritis ( OA ) Index on Motorola V3 mobile phones . STUDY DESIGN AND SETTING Patients with OA undergoing hip or knee joint replacement were assessed preoperatively and 3 - 4 months postoperatively , completing the WOMAC Index in paper ( p-WOMAC ) and electronic ( m-WOMAC ) format in r and om order . RESULTS Data were successfully and securely transmitted from patients in Australia to a server in the United States . Pearson correlations between the summated total index scores ( TISs ) for the p-WOMAC and m-WOMAC pre- and postsurgery were 0.98 and 0.99 ( P<0.0001 ) . There were no clinical ly important or statistically significant between- method differences in the adjusted total summated scores , pre- and postsurgery ( adjusted mean differences=4.44 , P=0.474 and 1.73 , P=0.781 , respectively ) . Internal consistency estimates of m-WOMAC reliability were 0.87 - 0.98 . The m-WOMAC detected clinical ly important , statistically significant ( P<0.0001 ) improvements in pain , stiffness , function , and TIS . No statistically significant differences in mode preference were detected . CONCLUSIONS There was close agreement and no significant differences between m-WOMAC and p-WOMAC scores . This study confirms the validity , reliability , and responsiveness of the Exco InTouch-engineered , Java-based m-WOMAC Index application . EDC with the m-WOMAC Index provides unique opportunities for using quantitative measurement in clinical research and practice Total hip arthroplasty has been associated with excellent implant survival rates , but debate remains concerning the best fixation method for the components . A r and omized controlled trial , which included 250 patients ( mean age , sixty-four years ) with osteoarthritis who were managed with total hip arthroplasty between October 1987 and January 1992 , was conducted to compare the results of fixation with and without cement .  Patients were followed for a mean of twenty years ( range , seventeen to twenty-one years ) .  Kaplan-Meier survivorship analysis at twenty years revealed significantly lower survival rates for cemented implants as compared with cementless implants . The cementless tapered stem had an extremely good survival rate of 99 % . Radiographs showed evidence of mild stress-shielding around 95 % of the cemented stems and 88 % of the cementless stems ; stress-shielding of grade 3 or greater was seen around the remaining 12 % of the cementless stems Cross-linked liners were introduced with the promise that they would substantially reduce polyethylene wear . In 1999 , our institution initiated a prospect i ve study to compare the outcome of total hip arthroplasty patients who were r and omized to non-cross-linked Enduron liners  with that of total hip arthroplasty patients who were r and omized to Marathon polyethylene liners that had been cross-linked with 5 Mrad ( 50 kGy ) of gamma-irradiation and heat-treated to eliminate free radicals . At a mean follow-up of 5.7 years , the clinical outcomes among the Marathon and Enduron liners were similar . However , the mean wear rate was 0.01 + /- 0.07 mm/y for the Marathon group , which represents a 95 % reduction compared with the mean wear rate of 0.19 + /- 0.12 mm/y for the Enduron group . In addition , the incidence of osteolysis was lower in the Marathon group BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients Background : This study was design ed to compare the fixation of a Mallory-Head total hip prosthesis with and without cement . Methods : Two hundred and fifty patients with osteoarthritis of the hip were r and omized to receive a Mallory-Head total hip prosthesis design ed for insertion with cement or the same prosthesis design ed for insertion without cement . Neither the patient nor the outcomes assessor was aware of the type of prosthesis . Outcomes were assessed with respect to mortality , revision arthroplasty , health-related quality of life ( evaluated with the Harris hip score , Merle d'Aubigné and Postel hip score , McMaster-Toronto Arthritis Patient Preference Disability Question naire ( MACTAR ) , Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , and the time trade-off technique ) , and the six-minute-walk test . Patients were seen at three , six , and twelve months and yearly thereafter . Results : The prosthesis was inserted with cement in 124 patients and without cement in 126 patients . The mean age of the patients was sixty-four years , 48 % were female , and the mean duration of follow-up was 6.3 years . There were thirteen revisions in the group that had fixation with cement and six in the group that had fixation without cement ( p = 0.11 ) , and more femoral components were revised in the group that had fixation with cement ( twelve versus one ; p = 0.002 ) . All health-related quality -of-life measures improved postoperatively in both groups . Conclusions : In this r and omized trial , the group that had the cemented Mallory-Head hip prostheses required more revisions of the femoral component than did the group with the cementless Mallory-Head prostheses , which was perhaps related to the titanium-alloy femoral stem . Our findings are specific to the implants evaluated in this study We developed a 12-item question naire for completion by patients having total hip replacement ( THR ) . A prospect i ve study of 220 patients was undertaken before operation and at follow-up six months later . Each completed the new question naire as well as the SF36 , and some the  Arthritis Impact Measurement Scales ( AIMS ) . An orthopaedic surgeon assessed the Charnley hip score . The single score derived from the question naire had a high internal consistency . Reproducibility was examined by test-retest reliability and was found to be satisfactory . The validity of the question naire was established by obtaining significant correlation in the expected direction with the Charnley scores and relevant scales of the SF36 and the AIMS . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at the follow-up . The st and ardised effect size for the new question naire compared favourably with that for the SF36 and the AIMS . The new question naire provides a measure of outcome for THR which is short , practical , reliable , valid and sensitive to clinical ly important changes The purpose of this investigation was to assess the midterm clinical outcomes after implantation of Oxinium ( OX ) vs cobalt-chrome ( CC ) femoral heads .  Primary total hip arthroplasty ( THA ) procedures were performed in 100 patients . After r and omization , half of the patients received OX femoral heads and half received CC femoral heads . At a minimum follow-up of 2-years , stem survival was 98 % for both groups . The mean Harris Hip score was 92 for OX and 92.5 for CC , with mean WOMAC scores of 84.9 and 87 , respectively . For SF-12 , the OX group had mean physical and mental component scores of 45.2 and 53.8 and the CC group 49.2 and 52.6 , respectively . At a minimum follow-up of 2 years , clinical outcomes for THA procedures using OX and CC femoral heads appear equivalent Research on surgical interventions is associated with several method ological and practical challenges of which few , if any , apply only to surgery . However ,  surgical evaluation  is especially dem and ing because many of these challenges coincide . In this report , the second of three on surgical innovation and evaluation , we discuss obstacles related to the study design of r and omised controlled trials and non-r and omised studies assessing surgical interventions . We also describe the issues related to the nature of surgical procedures -for example , their complexity , surgeon-related factors , and the range of outcomes . Although difficult , surgical evaluation is achievable and necessary . Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential The aim of this prospect i ve r and omised study was to compare the clinical and radiological results of a cemented all-polyethylene Ultima acetabular component with those of a cementless porous-coated acetabular component ( PFC ) following  total hip replacement ( THR ) . A total of 287 patients received either a polyethylene acetabular component ( group A ) or a cobalt-chromium porous-coated component ( group B ) with an identical cemented femoral component and 28 mm cobalt-chromium head , thus making it the largest study of its type . Patients were evaluated radiologically and clinical ly using the Harris hip score ( HHS ) .  Group A comprised 183 patients ( 73 male , 110 female ) with a mean age of 71.3 years ( 55 to 89 ) . Group B comprised 104 patients ( 48 male , 56 female ) with a mean age of 69.8 years ( 56 to 89 ) . A total of 16 patients ( 13 in Group A , three in Group B ) did not have post-operative data for analysis . The mean follow-up in group A was 7.52 years ( 0.4 to 15.0 ) and in Group B 7.87 years ( 0.5 to 14.0 ) . At final follow-up the mean HHS was similar between groups A and B ( 74.5 ( 25 to 100 ) and 78.0 ( 37 to 100 ) , respectively ; p = 0.068 ) . The total number of revisions for any cause was 28 , 17 of which were in group A and 11 in group B. The ten-year survivorship was 86.8 % ( 95 % confidence interval ( CI ) 78.4 to 92.1 ) and 89.2 % ( 95 % CI 78.3 to 94.8 ) for groups A and B , respectively ( log-rank p-value = 0.938 ) . A total of 20 cemented and two cementless acetabular components had evidence of acetabular radiolucencies or acetabular component migration at last follow-up ( p = 0.001 ) . These results indicate that patients with a cemented all-polyethylene and cementless porous-coated polyethylene lined acetabular component have similar long-term clinical outcomes
target: Patients experienced significant post-THR improvements in Harris Hip scores , but this did not differ between impact types .
  Recipients of cross-linked vs. conventional polyethylene cup liners experienced reduced femoral head penetration and revision .
  There was no impact of femoral stem fixation and cup shell design on implant survival rates .
  Evidence on mortality and complications ( aseptic loosening , femoral fracture ) was inconclusive .
background: BACKGROUND Evolvements in the design , fixation methods , size , and bearing surface of implants for  total hip replacement ( THR ) have led to a variety of options for healthcare professionals to consider .
  The need to determine the most optimal combinations of THR implant is warranted .
  This systematic review evaluated the clinical effectiveness of different types of THR used for the treatment of end stage arthritis of the hip .