Comparative study of knee anterior cruciate ligament reconstruction with or without fluoroscopic assistance: a prospective study of 73 cases. Comparison between single-and double-bundle anterior cruciate ligament reconstruction: a prospective, randomized, single-blinded clinical trial. Arthroscopically assisted reconstruction of the anterior cruciate ligament. A prospective randomized analysis of three techniques. Double-bundle versus single-bundle anterior cruciate ligament reconstruction: randomized clinical and magnetic resonance imaging study with 2-year follow-up.
Correct placement of both tibial and femoral tunnels is one of the main factors for a favorable clinical outcome after anterior cruciate ligament (ACL) reconstruction. We used an original system of computer assisted surgery (CAS). The system, based on fluoroscopic guidance combined with special graphical software of image analyzing, showed to the surgeon, before drilling, the recommended placement of tibial and femoral tunnel centers. We compared the first anatomical and clinical results of this procedure to the usual one single incision technique.
                We conducted a prospective study on 73 patients; 37 patients were operated on with CAS and 36 without CAS, by the same senior surgeon. The mean age was 27 years for both groups. Every patient was reviewed at an average of 2.2 years (range 1-4.5) by an independent observer, using IKDC scoring system, KT-1000, and passive stress radiographs.
                Time between ACL rupture and reconstruction averaged 30 months for both groups. CAS needed 9.3 min extra surgery time. Clinical evaluation was graded from A to C as per the IKDC scoring system: 67.6% A, 29.7% B, 2.7% C with CAS; and 60% A, 37.1% B, 2.9% C without CAS. IKDC subjective knee evaluation score averaged 89.7 with CAS and 89.5 without CAS. Pre operative KT-1000 maxi manual differential laxity averaged 7. At revision time, all the patients after CAS had a differential laxity less than 2 and 97.7% without CAS. Stress X-rays differential laxity averaged 2.4 mm with CAS and 3 mm without CAS. The area of dispersion of the tunnels' center was smaller on the femoral side using the CAS method. There was no statistically significant difference between both groups using IKDC score, KT-1000 and passive stress radiographs.
                The CAS method provided a more accurate and reproducible tunnels placement without clinical significant effect. Double-bundle ACL reconstruction popularity is increasing with the aim to reproduce native ACL anatomy and improve ACL reconstruction outcome. However, to date, only a few randomized clinical studies have been published.
                The aim of this study was to prospectively compare the clinical results of single- and double-bundle ACL reconstruction.
                Randomized controlled clinical trial; Level of evidence, 1.
                Seventy patients with a chronic unilateral ACL rupture who underwent arthroscopically assisted ACL reconstruction using a hamstring graft were randomized to receive a single- (SB) or double-bundle (DB) reconstruction. Both groups were comparable with regard to preoperative data. A double-incision surgical technique was adopted in both groups. The graft was fixed by looping the hamstring tendons around a bony (DB) or a metallic (SB) bridge on the tibial side and with interference screws reinforced with a staple on the femur. The same rehabilitation protocol was adopted. Outcome assessment was performed by a blinded, independent observer using the visual analog scale (VAS) score, the new International Knee Documentation Committee (IKDC) form, the Knee Injury and Osteoarthritis Outcome Score (KOOS), and KT-1000 arthrometer evaluation.
                All the patients reached a minimum follow-up of 2 years. No differences between the 2 groups were observed in terms of KOOS and IKDC subjective score. A statistically significant difference in favor of the DB group was found with the VAS (P < .03). The objective IKDC final scores showed statistically significantly more "normal knees" in the DB group than in the SB group (P = .03). There was 1 stability failure in the DB group and 3 in the SB group. The KT-1000 arthrometer data showed a statistically significant decrease in the average anterior tibial translation in the DB group (1.2 mm DB vs 2.1 mm SB; P < .03). The incidence of a residual pivot-shift glide was 14% in DB and 26% in SB (P = .08).
                In the 2-year minimum follow-up, DB ACL reconstructions showed better VAS, anterior knee laxity, and final objective IKDC scores than SB. However, longer follow-up and accurate instrumented in vivo rotational stability assessment are needed. One hundred and twenty-seven patients who had a rupture of the anterior cruciate ligament agreed to participate in a prospective, randomized study of three arthroscopically assisted reconstruction techniques. One hundred and twenty-five patients (125 reconstructions) were evaluated after a mean duration of follow-up of forty-two months (range, two to five years). Group I included forty patients who had a two-incision reconstruction with use of an autogenous semitendinosus-gracilis graft, group II consisted of forty patients who had a two-incision reconstruction with use of an autogenous patellar-ligament graft, and group III included forty-five patients who had a single-incision reconstruction (endoscopic technique) with use of an autogenous patellar-ligament graft. The male-female ratio, age range, level of athletic activity, interval between the injury and the reconstruction, previous operative procedures, and associated injuries were similar in all three groups. The same postoperative rehabilitation protocol was followed for all patients. Testing with a KT-2000 arthrometer at maximum manual force was done at the follow-up evaluation; the difference in laxity between the involved knee and the contralateral knee was three millimeters or less in thirty-three patients (83 per cent) in group I, thirty-seven patients (93 per cent) in group II, and thirty-nine patients (87 per cent) in group III. A difference of two millimeters or less was found in thirty patients (75 per cent) in group I, thirty-one patients (78 per cent) in group II, and thirty-five patients (78 per cent) in group III. Thirty-five patients (88 per cent) in group I, thirty-eight patients (95 per cent) in group II, and forty patients (89 per cent) in group III returned to at least the same level of athletic activity. Four grafts (two in group I and two in group II) failed as a result of trauma. There was one additional failure in groups I and III, as evidenced by a difference of nine and seven millimeters, respectively, on instrumented testing of laxity. The significant findings were that no knee was rated D according to the system of the International Knee Documentation Committee (p < 0.002, 94 per cent confidence level) and that fewer additional operative procedures were done on patients in group III (p < 0.08). Also, it was found that the patients in group II returned to a greater level of athletic activity (p < 0.02) and that a higher percentage of the patients in this group had a difference of three millimeters or less on testing with the KT-2000 arthrometer than in the other two groups (p < 0.08). However, with the numbers available, there were no significant differences in the over-all outcome among the three groups (p > 0.1). Importantly, the rate of failure was not greater and the outcomes were not less satisfactory for the late reconstructions than they were for the acute reconstructions (those performed less than three weeks after the injury), including those done with an autogenous semitendinosus-gracilis graft in a chronically unstable knee. One aspect of the debate over the reconstruction of the anterior cruciate ligament is whether it should be carried out with the single-bundle or double-bundle technique.
                The double-bundle technique results in fewer graft failures than the single-bundle technique in anterior cruciate ligament reconstruction.
                Randomized controlled trial; Level of evidence, 1.
                A total of 153 patients were prospectively randomized into 2 groups of anterior cruciate ligament reconstruction with hamstring autografts using aperture interference screw fixation: single-bundle technique (SB group, n = 78) and double-bundle technique (DB group, n = 75). The evaluation methods were clinical examination, KT-1000 arthrometric measurement, the International Knee Documentation Committee (IKDC) and the Lysholm knee scores, and magnetic resonance imaging (MRI) evaluation. All of the operations were performed by 1 experienced orthopaedic surgeon, and all clinical assessments were made by 2 blinded and independent examiners. A musculoskeletal radiologist blinded to the clinical data made the MRI interpretation.
                There were no differences between the study groups preoperatively. Ninety percent of patients (n = 138) were available at a minimum 2-year follow-up (range, 24-37 months). Eight patients (7 in the SB group and 1 in the DB group) had graft failure during the follow-up and had anterior cruciate ligament revision surgery (P = .04). In addition, 7 patients (5 in the SB group and 2 in the DB group) had an invisible graft on the MRI assessment at the 2-year follow-up. Also, the anteromedial bundle was partially invisible in 2 patients and the posterolateral bundle in 9 patients. Together, the total number of failures and invisible grafts were significantly higher in the SB group (12 patients, 15%) than the DB group (3 patients, 4%) (P = .024). No significant group differences were found in the knee scores or stability evaluations at the follow-up.
                This 2-year randomized trial showed that the revision rate of the anterior cruciate ligament reconstruction was significantly lower with the double-bundle technique than that with the single-bundle technique. However, additional years of follow-up are needed to reveal the long-term results.
A favourable effect of computer assisted surgery for cruciate ligament reconstructions of the knee compared with conventional reconstructions could neither be demonstrated nor refuted. There is insufficient evidence to advise for or against the use of CAS. There is a need for improved reporting of future studies of this technology.