## Protocol Section
### Identification Module
**NCT ID:** NCT05944679

**Brief Title:** Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery

**Official Title:** Prospective Randomized Study of the Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery

#### Organization Study ID Info
**ID:** Radioprotesi
#### Organization
**Class:** OTHER
**Full Name:** Corporacion Parc Tauli
### Status Module
#### Completion Date
**Date:** 2025-01-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-13

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-01-20

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-07-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-06-27
**Study First Submit QC Date:** 2023-07-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Corporacion Parc Tauli

#### Responsible Party

**Investigator Affiliation:** Corporacion Parc Tauli

**Investigator Full Name:** Xavier Pelfort Lopez

**Investigator Title:** Doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Primary prosthetic surgery for the treatment of gonarthrosis is currently one of the most prevalent surgical treatments in Traumatology. The Arthroplasty Register in Catalonia, which started in 2005, counted more than 60.000 knee prothesis until 2015. Regarding the peridiocity for taking control radiographs in patients undergoing knee replacement surgery, there is no consensus. This means, that in similar studies that evaluate the results of prosthetic surgery, there is a great variability in radiological follow-up protocols, especifically during the firts post-operative years. Given the high prevalence and the long survival period demonstrated by these implants, it seems reasonable to be able to establish the real value of the radiographs performed during the first year of follow-up after surgery. From this perspective, the aim of our study is to evaluate if conducting just two radiographs instead of five during the first postoperative year after the surgery, has any influence on the clinical and functional results of our patients.

### Conditions Module

**Conditions:**

- Prosthetic Knee Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Xray at 1, 3, 6 and 12 months

**Intervention Names:**

- Radiation: Xray

**Label:** Group Xray

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Xray at 12 months

**Intervention Names:**

- Radiation: No Xray

**Label:** Group No Xray

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group No Xray

**Description:** Just one Xray 12 months after the intervention

**Name:** No Xray

**Type:** RADIATION

#### Intervention 2

**Arm Group Labels:**

- Group Xray

**Description:** Xray at 1, 3, 6 and 12 months after intervention

**Name:** Xray

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment

**Measure:** KSS Test change

**Time Frame:** Preoperative, 6 and 12 months

**Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment

**Measure:** KOOS Test change

**Time Frame:** Preoperative, 6 and 12 months

**Description:** Change value from preoperative condition to 12 months after operation, including 6 month assessment

**Measure:** SF-12 Test change

**Time Frame:** Preoperative, 6 and 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who voluntarily agree to be part of the study and sign the informed consent
* Patients awaiting prosthetic knee surgery with a diagnosis of gonarthrosis without age limit (\>18 years)
* All cases of prothesis cemented to the tibia and femur will be included, regardless of whether or not the patellar component is prosthetic
* Patients with knee prothesis and cruciate ligament retention, with ultracongruent polyethylene or posterostabilized as a maximum degree of prosthetic constriction
* The implants will be the usual ones used in our Center for primary prosthetic knee surgery, Journey (smith-Nephew) and Persona or NexGen (Zimmer)

Exclusion Criteria:

* Patients who do not voluntariily agree to participate
* Patients undergoing primary prosthetic surgery in relation to tibial plate fractures
* Patients awaiting a unicompartimental or patellofemoral prothesis
* Patients who, for any reason, want to leave the study during the follow-up period

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xpelfort@tauli.cat

**Name:** Xavier Pelfort

**Phone:** +34937231010

**Role:** CONTACT

**Contact 2:**

**Email:** mmvinas@tauli.cat

**Name:** Mireia Viñas

**Phone:** +34937231010

**Phone Ext:** 21660

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sabadell

**Contacts:**

***Contact 1:***

- **Name:** Mireia

- **Phone Ext:** 21660

- **Role:** CONTACT

**Country:** Spain

**Facility:** Hospital Parc taulí

**State:** Barcelona

**Status:** RECRUITING

**Zip:** 08208

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 30782341

**Citation:** Gomez-Valero S, Garcia-Perez F, Florez-Garcia MT, Miangolarra-Page JC. A systematic review of self-administered questionnaires for the functional assessment of patients with knee disabilities adapted into Spanish. Rev Esp Cir Ortop Traumatol. 2017 Mar-Apr;61(2):96-103. doi: 10.1016/j.recot.2016.11.002. Epub 2017 Jan 31. English, Spanish.

**PMID:** 28159566

**Citation:** Walker LC, Clement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2018 Nov;26(11):3333-3341. doi: 10.1007/s00167-018-4879-5. Epub 2018 Feb 26. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2018 Apr 11;:

**PMID:** 29484445

**Citation:** Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.

**PMID:** 12801417

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**PMID:** 26122112

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**PMID:** 34204628

**Citation:** Sarmah SS, Patel S, Hossain FS, Haddad FS. The radiological assessment of total and unicompartmental knee replacements. J Bone Joint Surg Br. 2012 Oct;94(10):1321-9. doi: 10.1302/0301-620X.94B10.29411.

**PMID:** 23015555

**Citation:** Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989 Nov;(248):9-12.

**PMID:** 2805502

**Citation:** Khalifa AA, Mullaji AB, Mostafa AM, Farouk OA. A Protocol to Systematic Radiographic Assessment of Primary Total Knee Arthroplasty. Orthop Res Rev. 2021 Jul 17;13:95-106. doi: 10.2147/ORR.S320372. eCollection 2021.

**PMID:** 34305412

**Citation:** Baek JH, Lee SC, Choi K, Ahn HS, Nam CH. Long-term survivorship of total knee arthroplasty with a single-radius, high-flexion posterior stabilized prosthesis. Knee. 2021 Jun;30:275-282. doi: 10.1016/j.knee.2021.04.017. Epub 2021 May 11.

**PMID:** 33984746

**Citation:** Miralles-Munoz FA, Rubio-Morales M, Bello-Tejada L, Gonzalez-Parreno S, Lizaur-Utrilla A, Alonso-Montero C. Varus alignment of the tibial component up to seven degrees is not associated with poor long-term outcomes in a neutrally aligned total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2768-2775. doi: 10.1007/s00167-021-06627-3. Epub 2021 Jun 26.

**PMID:** 34175990

**Citation:** Sabatini L, Aprato A, Camazzola D, Bistolfi A, Capella M, Masse A. Primary total knee arthroplasty in tibial plateau fractures: Literature review and our institutional experience. Injury. 2023 Mar;54 Suppl 1:S15-S23. doi: 10.1016/j.injury.2021.02.006. Epub 2021 Feb 7.

**PMID:** 33583591

**Citation:** Webb JI, Stoner RS, Afzal I, Evans CR, Scott G, Field RE. The Medial Rotation Knee replacement: Clinical and radiological results of a multi-centre surveillance study at five years. Knee. 2021 Jan;28:247-255. doi: 10.1016/j.knee.2020.12.025. Epub 2021 Jan 13.

**PMID:** 33453513

**Citation:** Glaser D, Lotke P. Cost-effectiveness of immediate postoperative radiographs after uncomplicated total knee arthroplasty: a retrospective and prospective study of 750 patients. J Arthroplasty. 2000 Jun;15(4):475-8. doi: 10.1054/arth.2000.4338.

**PMID:** 10884208

**Citation:** Hassan S, Wall A, Ayyaswamy B, Rogers S, Mills SP, Charalambous CP. Is there a need for early post-operative x-rays in primary total knee replacements? Experience of a centre in the UK. Ann R Coll Surg Engl. 2012 Apr;94(3):199-200. doi: 10.1308/003588412X13171221501780. Erratum In: Ann R Coll Surg Engl. 2012 May;94(4):231. Ayyawamy, B [corrected to Ayyaswamy, B].

**PMID:** 22507727

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**PMID:** 34017659

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**PMID:** 29997704

#### See Also Links

**Label:** Knee and hip implants used in the National Health System

**URL:** https://aquas.gencat.cat/web/.content/minisite/aquas/publicacions/2021/implantes_cadera_rodilla_sns_redets_aquas_2021.pdf

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
