Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration.

BACKGROUND: Quantitative magnetic resonance imaging (qMRI) methods were developed to establish the integrity of healing anterior cruciate ligaments (ACLs) and grafts. Whether qMRI variables predict risk of reinjury is unknown. PURPOSE: To determine if qMRI measures at 6 to 9 months after bridge-enhanced ACL restoration (BEAR) can predict the risk of revision surgery within 2 years of the index procedure. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Originally, 124 patients underwent ACL restoration as part of the BEAR I, BEAR II, and BEAR III prospective trials and had consented to undergo an MRI of the surgical knee 6 to 9 months after surgery. Only 1 participant was lost to follow-up, and 4 did not undergo MRI, leaving a total of 119 patients for this study. qMRI techniques were used to determine the mean cross-sectional area; normalized signal intensity; and a qMRI-based predicted failure load, which was calculated using a prespecified equation based on cross-sectional area and normalized signal intensity. Patient-reported outcomes (International Knee Documentation Committee subjective score), clinical measures (hamstring strength, quadriceps strength, and side-to-side knee laxity), and functional outcomes (single-leg hop) were also measured at 6 to 9 months after surgery. Univariate and multivariable analyses were performed to determine the odds ratios (ORs) for revision surgery based on the qMRI and non-imaging variables. Patient age and medial posterior tibial slope values were included as covariates. RESULTS: In total, 119 patients (97%), with a median age of 17.6 years, underwent MRI between 6 and 9 months postoperatively. Sixteen of 119 patients (13%) required revision ACL surgery. In univariate analyses, higher International Knee Documentation Committee subjective score at 6 to 9 months postoperatively (OR = 1.66 per 10-point increase; P = .035) and lower qMRI-based predicted failure load (OR = 0.66 per 100-N increase; P = .014) were associated with increased risk of revision surgery. In the multivariable model, when adjusted for age and posterior tibial slope, the qMRI-based predicted failure load was the only significant predictor of revision surgery (OR = 0.71 per 100 N; P = .044). CONCLUSION: Quantitative MRI-based predicted failure load of the healing ACL was a significant predictor of the risk of revision within 2 years after BEAR surgery. The current findings highlight the potential utility of early qMRI in the postoperative management of patients undergoing the BEAR procedure.

Preoperative Risk Factors for Subsequent Ipsilateral ACL Revision Surgery After an ACL Restoration Procedure.

BACKGROUND: Anterior cruciate ligament (ACL) revision surgery is challenging for both patients and surgeons. Understanding the risk factors for failure after bridge-enhanced ACL restoration (BEAR) may help with patient selection for ACL restoration versus ACL reconstruction. PURPOSE: To identify the preoperative risk factors for ACL revision surgery within the first 2 years after BEAR. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: Data from the prospective BEAR I, II, and III trials were used to determine the preoperative risk factors for ACL revision surgery. All patients with a complete ACL tear (aged 13-47 years, depending on the trial), who met all other inclusion/exclusion criteria and underwent a primary BEAR procedure within 30 to 50 days from the injury (dependent on the trial), were included. Demographic data (age, sex, body mass index), baseline patient-reported outcomes (International Knee Documentation Committee [IKDC] subjective score, Marx activity score), preoperative imaging results (ACL stump length, notch size, tibial slope), and intraoperative findings (knee hyperextension, meniscal status) were evaluated to determine their contribution to the risk of ipsilateral ACL revision surgery. RESULTS: A total of 123 patients, with a median age of 17.6 years (interquartile range, 16-23 years), including 67 (54%) female patients, met study criteria. Overall, 18 (15%) patients required ACL revision surgery in the first 2 years after the BEAR procedure. On bivariate analyses, younger age (P = .011), having a contact injury at the time of the initial tear (P = .048), and increased medial tibial slope (MTS; P = .029) were associated with a higher risk of ipsilateral revision surgery. Multivariable logistic regression analyses identified 2 independent predictors of revision: patient age and MTS. The odds of ipsilateral revision surgery were decreased by 32% for each 1-year increase in age (odds ratio, 0.684 [95% CI, 0.517-0.905]; P = .008) and increased by 28% for each 1° increase in MTS (odds ratio, 1.280 [95% CI, 1.024-1.601]; P = .030). Sex, baseline IKDC or Marx score, knee hyperextension, and meniscal status were not significant predictors of revision. CONCLUSION: Younger age and higher MTS were predictors of ipsilateral ACL revision surgery after the BEAR procedure. Younger patients with higher tibial slopes should be aware of the increased risk for revision surgery when deciding to undergo ACL restoration.

Hydrogel treatment for idiopathic osteoarthritis in a Dunkin Hartley Guinea pig model.

The study objective was to determine if intraarticular injections of an extracellular matrix (ECM) powder and blood composite (ECM-B) would have a significant impact on post-operative gait parameters without eliciting adverse cartilage changes or severe lymphatic reactions in an idiopathic osteoarthritis (OA) model. Twenty-one Dunkin Hartley Guinea pigs received an intraarticular injection of ECM-B in each knee and were split into sub-groups for gait assessment and post-harvest knee evaluations at 1 week (n = 5), 2 weeks (n = 5), 4 weeks (n = 5), or 8 weeks (n = 6). The results were compared with a control group (n = 5), which underwent bilateral injections of phosphate-buffered saline (PBS), gait measurements at 1, 2, 4, and 8 weeks, and post-mortem knee evaluation at 8 weeks post-injection. Hind limbs and popliteal lymph nodes were collected at the Week 8 endpoint and underwent histological analysis by a veterinary pathologist. Significant improvement in hind limb base of support was observed in the ECM-B group compared to the control group at Week 4 but was no longer significant by Week 8. No significant differences were observed between control and ECM-B groups in hind limb cartilage, synovium, or popliteal lymph node histology at Week 8. In conclusion, administration of an ECM-B material may improve gait for a limited time without significant adverse effects on the cartilage, synovium, or local lymph nodes.

Changes in the Cross-Sectional Profile of Treated Anterior Cruciate Ligament Within 2 Years After Surgery.

Background: The cross-sectional area (CSA) of the anterior cruciate ligament (ACL) and reconstructed graft has direct implications on its strength and knee function. Little is known regarding how the CSA changes along the ligament length and how those changes vary between treated and native ligaments over time. Hypothesis: It was hypothesized that (1) the CSA of reconstructed ACLs and restored ACLs via bridge-enhanced ACL restoration (BEAR) is heterogeneous along the length. (2) Differences in CSA between treated and native ACLs decrease over time. (3) CSA of the surgically treated ACLs is correlated significantly with body size (ie, height, weight, body mass index) and knee size (ie, bicondylar and notch width). Study Design: Cohort study; Level of evidence, 2. Methods: Magnetic resonance imaging scans of treated and contralateral knees of 98 patients (n = 33 ACL reconstruction, 65 BEAR) at 6, 12, and 24 months post-operation were used to measure the ligament CSA at 1% increments along the ACL length (tibial insertion, 0%; femoral insertion, 100%). Statistical parametric mapping was used to evaluate the differences in CSA between 6 and 24 months. Correlations between body and knee size and treated ligament CSA along its length were also assessed. Results: Hamstring autografts had larger CSAs than native ACLs at all time points (P < .001), with region of difference decreasing from proximal 95% of length (6 months) to proximal 77% of length (24 months). Restored ACLs had larger CSAs than native ACLs at 6 and 12 months, with larger than native CSA only along a small midsubstance region at 24 months (P < .001). Graft CSA was correlated significantly with weight (6 and 12 months), bicondylar width (all time points), and notch width (24 months). Restored ACL CSA was significantly correlated with bicondylar width (6 months) and notch width (6 and 12 months). Conclusion: Surgically treated ACLs remodel continuously within the first 2 years after surgery, leading to ligaments/grafts with heterogeneous CSAs along the length, similar to the native ACL. While reconstructed ACLs remained significantly larger, the restored ACL had a CSA profile comparable with that of the contralateral native ACL. In addition to size and morphology differences, there were fundamental differences in factors contributing to CSA profile between the ACL reconstruction and BEAR procedures. Registration: NCT02664545 (ClinicalTrials.gov identifier).

Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial.

BACKGROUND: Previous clinical studies have shown that psychological factors have significant effects on an athlete's readiness to return to sport after anterior cruciate ligament (ACL) reconstruction (ACLR). HYPOTHESIS: We hypothesized that patients who underwent bridge-enhanced ACL restoration (BEAR) would have higher levels of psychological readiness to return to sport compared with patients who underwent ACLR. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 100 patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were randomized to either the BEAR procedure (n = 65) or autograft ACLR (n = 35 [33 hamstring and 2 bone--patellar tendon-bone]) and underwent surgery within 45 days of injury. Objective, functional, and patient-reported outcomes, including the ACL--Return to Sport after Injury (ACL-RSI) scale, were assessed at 6, 12, and 24 months postoperatively. RESULTS: Patients who underwent the BEAR procedure had significantly higher ACL-RSI scores at 6 months compared with those who underwent ACLR (71.1 vs 58.2; P = .008); scores were similar at 12 and 24 months. Baseline factors independently predictive of higher ACL-RSI scores at 6 months were having a BEAR procedure and participating in level 1 sports prior to injury, explaining 15% of the variability in the scores. Regression analysis of baseline and 6-month outcomes as predictors indicated that the International Knee Documentation Committee (IKDC) score at 6 months explained 45% of the 6-month ACL-RSI variance. Subsequent analysis with IKDC excluded from the model indicated that decreased pain, increased hamstring and quadriceps strength in the surgical limb, and decreased side-to-side difference in anteroposterior knee laxity were significant predictors of a higher ACL-RSI score at 6 months, explaining 34% of the variability in scores. Higher ACL-RSI score at 6 months was associated with earlier clearance to return to sports. CONCLUSION: Patients who underwent the BEAR procedure had higher ACL-RSI scores at 6 months postoperatively. Better ACL-RSI scores at 6 months were related most strongly to higher IKDC scores at 6 months and were also associated with lower pain levels, better muscle recovery, and less knee laxity at 6 months. REGISTRATION: NCT02664545 (ClinicalTrials.gov identifier).

Effects of radiation dose and nitrogen purge on collagen scaffold properties.

Sterilization of medical devices is commonly performed using radiation methods. However, collagen materials can be damaged when using standard radiation doses (25 kGy). Small increases of radiation dose can allow for increases in the acceptable initial bioburden load of aseptically manufactured devices while maintaining required sterility assurance levels, which is often critical in early stage translational settings. In this study, we hypothesized that small increases in radiation dose from 15 to 20 kGy would result in significant changes to several key characteristics of collagen scaffolds. Scaffolds were manufactured by lyophilizing the pepsin digest of dense bovine connective tissue in cylindrical molds and were irradiated at either 0, 15, 17.5, or 20 kGy with an additional group packaged in nitrogen and irradiated at 17.5 kGy. Groups were evaluated for changes to the soluble collagen and glycosaminoglycan mass fractions, protein banding patterns in electrophoresis, a collagen fragmentation assay, and resistance to enzymatic degradation. All parameters were statistically analyzed using one-way analysis of variance with Tukey's correction for multiple comparisons. The soluble collagen mass fraction was significantly decreased in the 20 kGy group; however, there was no significant effect of radiation dose or a nitrogen-rich environment on the other measured parameters, including protein banding patterns, fragmented collagen content, and resistance to enzymatic degradation.Statement of Clinical Significance: Collagen scaffolds have proven useful in clinical applications but can be damaged by standard radiation doses. Low-dose sterilization may be a viable alternative that minimally impacts key properties of these scaffolds.

Terminal sterilization influences the efficacy of an extracellular matrix-blood composite for treating posttraumatic osteoarthritis in the rat model.

The objective was to determine if an intra-articular injection of an extracellular matrix (ECM) powder and blood composite (ECM-B) after anterior cruciate ligament (ACL) injury would have a mitigating effect on posttraumatic osteoarthritis and if that effect would be different with terminal sterilization of the ECM powder before use. Eighty Lewis rats underwent ACL transection and were divided into four groups: (1) intra-articular injection with phosphate-buffered saline (PBS; n = 20), (2) intra-articular injection of ECM-B using aseptically processed ECM (ASEPTIC; n = 20), (3) intra-articular injection of the ECM-busing ECM powder sterilized with 15 kGy electron beam irradiation (EBEAM; n = 20), and (4) intra-articular injection of the ECM-B using ECM powder sterilized with ethylene oxide (EO; n = 20). Twenty additional animals received capsulotomy only (SHAM). The animals were followed for 6 weeks and evaluations of gait, radiographs, and joint cartilage histology were performed. At 6 weeks, when compared to the SHAM group, the group treated with PBS had significantly worse gait and histologic changes, while the ASEPTIC group was not different from SHAM for either of these outcomes. When compared to the SHAM group, the EO group had similar gait outcomes, but greater histologic damage, and the EBEAM group had significantly worse gait and histological outcomes. The ECM-B composite produced using aseptically processed ECM powder mitigated the gait and histologic changes associated with osteoarthritis after ACL transection in the rat; however, care must be taken when selecting a terminal sterilization method as this may affect the effectiveness of treatment.

Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction.

BACKGROUND: Bridge-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. HYPOTHESIS: It 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 DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A 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. RESULTS: Repeated-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). CONCLUSION: Patients 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. REGISTRATION: NCT02664545 (ClinicalTrials.gov identifier).

Regional Differences in Anterior Cruciate Ligament Signal Intensity After Surgical Treatment.

BACKGROUND: Magnetic resonance-based measurements of signal intensity have been used to track healing of surgically treated anterior cruciate ligaments (ACLs). However, it is unknown how the signal intensity values in different regions of the ligament or graft change during healing. HYPOTHESES: (1) Normalized signal intensity of the healing graft or repaired ACL is heterogeneous; (2) temporal changes in normalized signal intensity values differ among the tibial, middle, and femoral regions; and (3) there are no differences in regional normalized signal intensity values 2 years postoperatively among grafts, repaired ACLs, and contralateral native ACLs. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Magnetic resonance imaging scans were analyzed from patients in a trial comparing ACL reconstruction (n = 35) with bridge-enhanced ACL repair (n = 65). The ACLs were segmented from images acquired at 6, 12, and 24 months postoperatively and were partitioned into 3 sections along the longitudinal axis (femoral, middle, and tibial). Linear mixed modeling was used to compare location-specific differences in normalized ligament signal intensity among time points (6, 12, and 24 months) and groups (ACL reconstruction, repair, and contralateral native ACL). RESULTS: For grafts, the middle region had a higher mean normalized signal intensity when compared with the femoral region at all time points (P < .01) but compared with the tibial region only at 6 months (P < .01). For repaired ACLs, the middle region had a higher mean normalized signal intensity versus the femoral region at all time points (P < .01) but versus the tibial region only at 6 and 12 months (P < .04). From 6 to 24 months, the grafts showed the greatest reduction in normalized signal intensity in the femoral and middle regions (vs tibial regions; P < .01), while there were no regional differences in repaired ACLs. At 2 years after surgery, repaired ACLs had a lower normalized signal intensity in the tibial region as compared with reconstructed grafts and contralateral native ACLs (P < .01). CONCLUSION: The results suggest that graft remodeling is location specific. Repaired ACLs were more homogeneous, with lower or comparable normalized signal intensity values at 2 years as compared with the contralateral native ACL and reconstructed grafts.

ACL Size, but Not Signal Intensity, Is Influenced by Sex, Body Size, and Knee Anatomy.

BACKGROUND: Little is known about sex-based differences in anterior cruciate ligament (ACL) tissue quality in vivo or the association of ACL size (ie, volume) and tissue quality (ie, normalized signal intensity on magnetic resonance imaging [MRI]) with knee anatomy. HYPOTHESIS: We hypothesized that (1) women have smaller ACLs and greater ACL normalized signal intensity compared with men, and (2) ACL size and normalized signal intensity are associated with age, activity levels, body mass index (BMI), bicondylar width, intercondylar notch width, and posterior slope of the lateral tibial plateau. STUDY DESIGN: Cross-sectional study; Level of evidence, 3. METHODS: Knee MRI scans of 108 unique ACL-intact knees (19.7 ± 5.5 years, 62 women) were used to quantify the ACL signal intensity (normalized to cortical bone), ligament volume, mean cross-sectional area, and length. Independent t tests were used to compare the MRI-based ACL parameters between sexes. Univariate and multivariate linear regression analyses were used to investigate the associations between normalized signal intensity and size with age, activity levels, BMI, bicondylar width, notch width, and posterior slope of the lateral tibial plateau. RESULTS: Compared with men, women had significantly smaller mean ACL volume (men vs women: 2028 ± 472 vs 1591 ± 405 mm3), cross-sectional area (49.4 ± 9.6 vs 41.5 ± 8.6 mm2), and length (40.8 ± 2.8 vs 38.1 ± 3.1 mm) (P < .001 for all), even after adjusting for BMI and bicondylar width. There was no difference in MRI signal intensity between men and women (1.15 ± 0.24 vs 1.12 ± 0.24, respectively; P = .555). BMI, bicondylar width, and intercondylar notch width were independently associated with a larger ACL (R 2 > 0.16, P < .001). Younger age and steeper lateral tibial slope were independently associated with shorter ACL length (R 2 > 0.03, P < .04). The combination of BMI and bicondylar width was predictive of ACL volume and mean cross-sectional area (R 2 < 0.3). The combination of BMI, bicondylar width, and lateral tibial slope was predictive of ACL length (R 2 = 0.39). Neither quantified patient characteristics nor anatomic variables were associated with signal intensity. CONCLUSION: Men had larger ACLs compared with women even after adjusting for BMI and knee size (bicondylar width). No sex difference was observed in signal intensity, suggesting no difference in tissue quality. The association of the intercondylar notch width and lateral tibial slope with ACL size suggests that the influence of these anatomic features on ACL injury risk may be partially explained by their effect on ACL size. REGISTRATION: NCT02292004 and NCT02664545 (ClinicalTrials.gov identifier).

Higher Physiologic Platelet Counts in Whole Blood Are Not Associated With Improved ACL Cross-sectional Area or Signal Intensity 6 Months After Bridge-Enhanced ACL Repair.

BACKGROUND: A bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR) procedure places an extracellular matrix implant, combined with autologous whole blood, in the gap between the torn ends of the ligament at the time of suture repair to stimulate healing. Prior studies have suggested that white blood cell (WBC) and platelet concentrations significantly affect the healing of other musculoskeletal tissues. PURPOSE/HYPOTHESIS: The purpose of this study was to determine whether concentrations of various blood cell types placed into a bridging extracellular matrix implant at the time of ACL repair would have a significant effect on the healing ligament cross-sectional area or tissue organization (as measured by signal intensity). We hypothesized that patients with higher physiologic platelet and lower WBC counts would have improved healing of the ACL on magnetic resonance imaging (MRI) (higher cross-sectional area and/or lower signal intensity) 6 months after surgery. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: A total of 61 patients underwent MRI at 6 months after bridge-enhanced ACL repair as part of the BEAR II trial. The normalized signal intensity and average cross-sectional area of the healing ligament were measured from a magnetic resonance stack obtained using a gradient echo sequence. The results were stratified by sex, and univariate and multivariate regression analyses determined significant correlations between blood cell concentrations on these 2 magnetic resonance parameters. RESULTS: In unadjusted analyses, older age and male sex were associated with greater healing ligament cross-sectional area (P < .04) but not signal intensity (P > .15). Adjusted multivariable analyses indicated that in female patients, a higher monocyte concentration correlated with a higher ACL cross-sectional area (ß = 1.01; P = .049). All other factors measured, including the physiologic concentration of platelets, neutrophils, lymphocytes, basophils, and immunoglobulin against bovine gelatin, were not significantly associated with either magnetic resonance parameter in either sex (P > .05 for all). CONCLUSION: Although older age, male sex, and monocyte concentration in female patients were associated with greater healing ligament cross-sectional area, signal intensity of the healing ligament was independent of these factors. Physiologic platelet concentration did not have any significant effect on cross-sectional area or signal intensity of the healing ACL at 6 months after bridge-enhanced ACL repair in this cohort. Given these findings, factors other than the physiologic platelet concentration and total WBC concentration may be more important in the rate and amount of ACL healing after bridge-enhanced ACL repair.

Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair.

Background: While a sex effect on outcomes following anterior cruciate ligament (ACL) reconstruction surgery has been previously documented, less is known following bridge-enhanced ACL repair (BEAR). We hypothesized that female sex would have significantly worse early functional outcomes and higher retear rates following primary repair of the ACL enhanced with a tissue-engineered scaffold. Methods: Sixty-five patients (28 males and 37 females), age 14-35 with a complete ACL tear underwent primary repair of the ACL enhanced with a tissue-engineered scaffold (bridge-enhanced ACL repair) within 45 days of injury. International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome (KOOS) scores, as well as instrumented anteroposterior (AP) laxity through KT-1000 testing and functional outcome measures were obtained at time points up to 2 years postoperatively and compared between males and females using mixed model repeated measures analyses and chi square tests. Results: There was no significant sex difference on the postoperative IKDC Subjective Score at 3, 6, 12, or 24 months or any of the five KOOS scores at 12 and 24 months. Instrumented AP laxity testing demonstrated mean (standard deviation) side-to-side differences that were similar in the two sexes at 2 years; 1.7 (2.7) mm and 1.5 (3.7) mm in females and males, respectively, p = 0.72. At 6 months postoperatively, males had a larger deficit in hamstring strength on the operated leg (14.0% vs. 1.7%; p = 0.03) and a larger deficit in quadriceps strength on the operated leg (11.3% vs. 2.0%; p = 0.004); however, no sex difference was noted at 12 or 24 months. Females demonstrated superior single leg hop testing at 6 and 12 months ([91.3% vs. 78.1%, p = 0.001], [96.9% vs. 87.0%, p = 0.01] respectively). There were no significant sex differences on ipsilateral (males; 14.3% vs. females; 13.9%, p = 1.00) or contralateral (males; 3.6% vs. females; 2.8%, p = 1.00) ACL reinjury rates. Conclusions: Female subjects had better hamstring and quadriceps strength indices at 6 months than males as well as better hop test results at the 6 and 12-month time period. Despite this, there was no significant sex difference on patient-reported outcomes and objective AP laxity testing at time points up to 2 years postoperatively. Impact statement This is the first study comparing sex specific outcomes following the bridge-enhanced ACL repair technique (BEAR). The results of this study suggest that females have earlier recovery of both muscle strength and functional outcomes compared to their male counterparts. This is an important finding when considering future modifications to postoperative care and rehabilitation in females and males following this tissue-engineered BEAR technique.

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.

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).