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Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial.

ABSTRACT: BACKGROUND:Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). HYPOTHESIS:We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, -11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft. STUDY DESIGN:Randomized controlled trial; Level of evidence, 1. METHODS:One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone-patellar tendon-bone]). Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. Patients were unblinded after their 2-year visit. RESULTS:In total, 96% of the patients returned for 2-year follow-up. Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, -1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, -0.15 mm [95% CI, -1.48 to 1.17]). The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P < .001). In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure (P = .32). Furthermore, the 8 patients who converted from BEAR to ACLR in the study period and returned for the 2-year postoperative visit had similar primary outcomes to patients who had a single ipsilateral ACL procedure. CONCLUSION:BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. These promising results suggest that longer-term studies of this technique are justified. REGISTRATION:NCT02664545 (ClinicalTrials.gov identifier).

SUBMITTER: Murray MM

PROVIDER: S-EPMC7227128 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial.

Murray Martha M MM Fleming Braden C BC Badger Gary J GJ Freiberger Christina C Henderson Rachael R Barnett Samuel S Kiapour Ata A Ecklund Kirsten K Proffen Benedikt B Sant Nicholas N Kramer Dennis E DE Micheli Lyle J LJ Yen Yi-Meng YM

The American journal of sports medicine 20200416 6

<h4>Background</h4>Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR).<h4>Hypothesis</h4>We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; ...[more]

PMID: 32298131

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Project description:PurposeTo compare postoperative pain scores and opioid use between patients undergoing a standard arthroscopic anterior cruciate ligament reconstruction (ACLR) using hamstring autograft with those undergoing a suture repair augmented with an extracellular matrix scaffold (bridge-enhanced ACL repair) performed through an arthrotomy and to determine factors predictive of postoperative opioid use and levels of overprescription.MethodsA nonrandomized controlled trial was conducted with 20 patients (10 ACLR, 10 bridge-enhanced ACL repair), aged 18 to 35 years. All surgeries were performed by a single surgeon. A pain medication log was provided to patients on discharge. No regional anesthesia was performed. Pain scores via a visual analog pain scale were recorded at each visit. Correlations between preoperative and intraoperative characteristics and postoperative opioid use were determined.ResultsThe total morphine-equivalent dose ranged from 30 to 309 mg (4-42 pills oxycodone) for the ACLR group and 75 to 254 mg (10-34 pills oxycodone) for the bridge-enhanced ACL repair group. The average opioid use per day was 35.8 mg for the patients undergoing bridge-enhanced ACL repair and 44.2 mg for patients undergoing ACLR (P = .29). Pain scores at time points up to 2 years postoperatively were not significantly different between the 2 groups. Across both groups, the average oversupply of oxycodone was 46 pills per patient, a greater than 70% unused opiate rate. Preoperative body mass index and preoperative Knee Injury and Osteoarthritis Outcome Scores pain score were predictive of greater postoperative opioid use per day, whereas age, concurrent meniscal repair, and operative time were not.ConclusionsTotal overall opiate intake was not different between the patients undergoing bridge-enhanced ACL repair through an arthrotomy and those undergoing arthroscopic ACLR. Both groups had similar pain scores from 2 weeks to 2 years postoperatively. Greater body mass index and greater preoperative pain (lower Knee Injury and Osteoarthritis Outcome Scores pain score) correlated with greater postoperative opioid use per day. There was an overprescription of opioids across all patients.Level of evidenceLevel III, case control study (therapeutic).

Project description:BackgroundBridge-enhanced anterior cruciate ligament repair (BEAR) has noninferior patient-reported outcomes when compared with autograft anterior cruciate ligament reconstruction (ACLR) at 2 years. However, the comparison of BEAR and autograft ACLR at earlier time points-including important outcomes such as resolution of knee pain and symptoms, recovery of strength, and return to sport-has not yet been reported.HypothesisIt was hypothesized that the BEAR group would have higher outcomes on the International Knee Documentation Committee and Knee injury and Osteoarthritis Outcome Score, as well as improved muscle strength, in the early postoperative period.Study designRandomized controlled trial; Level of evidence, 1.MethodsA total of 100 patients aged 13 to 35 years with complete midsubstance anterior cruciate ligament injuries were randomized to receive a suture repair augmented with an extracellular matrix implant (n = 65) or an autograft ACLR (n = 35). Outcomes were assessed at time points up to 2 years postoperatively. Mixed-model repeated-measures analyses were used to compare BEAR and ACLR outcomes. Patients were unblinded after their 2-year visit.ResultsRepeated-measures testing revealed a significant effect of group on the International Knee Documentation Committee Subjective Score (P = .015), most pronounced at 6 months after surgery (BEAR = 86 points vs ACLR = 78 points; P = .001). There was a significant effect of group on the Knee injury and Osteoarthritis Outcome Score-Symptoms subscale scores (P = .010), largely attributed to the higher BEAR scores at the 1-year postoperative time point (88 vs 82; P = .009). The effect of group on hamstring strength was significant in the repeated-measures analysis (P < .001), as well as at all postoperative time points (P < .001 for all comparisons). At 1 year after surgery, approximately 88% of the patients in the BEAR group and 76% of the ACLR group had been cleared for return to sport (P = .261).ConclusionPatients undergoing the BEAR procedure had earlier resolution of symptoms and increased satisfaction about their knee function, as well as improved resolution of hamstring muscle strength throughout the 2-year follow-up period.RegistrationNCT02664545 (ClinicalTrials.gov identifier).

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Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial.

Publications

Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial.

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