前交叉韧带重建术中固定袢与可调节袢悬吊固定对膝关节客观松弛度及患者报告结局指标无差异：GAP研究1年结果——一项前瞻性双盲随机试验
简介
这是一项前瞻性、双盲、随机对照试验（GAP研究），纳入164例接受腘绳肌腱自体移植物ACL重建的患者，比较股骨侧固定袢（G-Lock）与可调袢（ProCinch）悬吊固定的临床效果。1年随访时，121例患者完成评估（固定袢组58例，可调袢组63例）。两组在150N和200N推力下的患膝松弛度（GNRB关节动度计测量）无显著差异（150N：5.51 mm vs…
英文摘要
INTRODUCTION: Suspensory fixation is one of the most common graft fixation methods in anterior cruciate ligament (ACL) reconstruction and can be performed with either a fixed-loop device or adjustable-loop device. There has, however, been a paucity of comparative clinical data and a clear need for an adequately powered, double-blinded, randomized study. to determine whether there is any difference in objective knee laxity between these fixation methods. The GAP study was designed to address this need. METHODS: In a single-centre, two-surgeon series, 164 patients were recruited and randomized to receive a hamstring autograft ACL reconstruction using either a fixed-loop or adjustable-loop femoral fixation (Stryker G-Lock or ProCinch, respectively). Patients and assessors were blinded. Knee laxity was the primary outcome measure and measurements were taken using the GNRB (Genourob, Laval, France) knee arthrometer set at 150N and 200N respectively. Measurements were taken from the operated leg and compared to the contralateral leg. Patient reported outcome measures (PROMs) were collected at baseline, 6 months and 12 months and a linear regression analysis was undertaken. RESULTS: At 1-year, 121 patients (62% male; mean age 31, SD 9.8) had complete knee laxity assessments. Of these, 58 received the fixed-loop fixation and 63 the adjustable-loop device. At 150N, the operated-knee laxity in the fixed-loop group was 5.51mm (SD 1.40; 95% CI 5.14-5.87) versus 5.61mm (SD 1.39; 95% CI 5.26-5.96) in the adjustable-loop group (P=0.68). At 200N, the operated-knee laxity in the fixed-loop group was 6.94mm (SD 1.54; 95% CI 6.53-7.34) versus 7.02mm (SD 1.53; 95% CI 6.63-7.40) in the adjustable-loop group (P=0.77). There was no statistically significant difference in the between-knee laxity measurements or PROMs (Tegner Activity Score, International Knee Documentation Committee [IKDC] Subjective Knee Evaluation Form, Lysholm Score, or any of the Knee injury and Osteoarthritis Outcome Score [KOOS] domains) between the groups. CONCLUSION: The GAP study is the first to compare knee laxity measurements between these two graft fixation devices in a randomized and blinded study. No statistically significant differences were observed in absolute or relative (operated vs. non-operated) knee laxity measurements or PROMs. These important new findings should inform surgeons and patients when considering graft fixation choice in ACL reconstruction. This study also provides new reference data for the operated and non-operated knees of patients following hamstring autograft ACL reconstruction. LEVEL OF EVIDENCE: Level 1 prospective, double-blinded, randomized controlled trial. TRIAL REGISTRATION: NCT03184922 (ClinicalTrials.gov).