Dataset Information

Bridge-Enhanced Anterior Cruciate Ligament Restoration: 6-Year Results From the First-in-Human Cohort Study.

ABSTRACT:

Background

Bridge-enhanced anterior cruciate ligament restoration (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with an extracellular matrix implant plus autologous blood to facilitate native ACL healing.

Purpose/hypothesis

The purpose of this study was to compare the 6-year follow-up outcomes of patients who underwent the BEAR procedure with those of a nonrandomized concurrent control group receiving autograft ACL reconstruction (ACLR) in the first-in-human safety study of the BEAR implant (BEAR I trial). Based on the 2-year results, it was hypothesized that isometric hamstring strength after the BEAR procedure would be greater than that after ACLR and that there would be no other differences in outcomes at 6 years.

Study design

Cohort study, Level of evidence, 2.

Methods

Ten patients underwent BEAR and 10 received ACLR with a 4-stranded hamstring autograft. Outcomes assessed included the record of subsequent surgeries, the International Knee Documentation Committee (IKDC) Subjective Knee Score, IKDC physical examination grade, the Knee injury and Osteoarthritis Outcome Score, instrumented knee laxity, functional outcomes (ie, muscle strength assessments and hop testing), and qualitative magnetic resonance imaging assessment. Comparisons between treatments were based on computations of the mean differences and the associated 95% CIs.

Results

One patient in the BEAR group and 3 patients in the ACLR group were lost to follow-up. In the period between 2 and 6 years, 1 patient in each group underwent revision surgery. There were no differences between groups at the 6-year follow-up in any of the outcome measures except for isometric hamstring strength, which was approximately equal to that of the contralateral knee in the BEAR group and <44% of that in the contralateral knee in the ACLR group (P < .01).

Conclusion

This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up and warrants investigation of the BEAR procedure in a larger cohort of patients.

SUBMITTER: Fleming BC

PROVIDER: S-EPMC11322937 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Bridge-Enhanced Anterior Cruciate Ligament Restoration: 6-Year Results From the First-in-Human Cohort Study.

Fleming Braden C BC Baranker Ben B Badger Gary J GJ Kiapour Ata M AM Ecklund Kirsten K Micheli Lyle J LJ Murray Martha M MM

Orthopaedic journal of sports medicine 20240813 8

<h4>Background</h4>Bridge-enhanced anterior cruciate ligament restoration (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with an extracellular matrix implant plus autologous blood to facilitate native ACL healing.<h4>Purpose/hypothesis</h4>The purpose of this study was to compare the 6-year follow-up outcomes of patients who underwent the BEAR procedure with those of a nonrandomized concurrent control group receiving autograft ACL reconstruction (ACLR) in the first-in-huma ...[more]

PMID: 39143986

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Project description:BackgroundBridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing.Purpose/hypothesisThe purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group.Study designCohort study; Level of evidence, 2.MethodsTen patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.ResultsThere were no graft or repair failures in the first 24 months after surgery. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 ± 2.08 mm; ACLR, 3.14 ± 2.66 mm). Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001).ConclusionIn this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients.

Project description:BackgroundThis study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there would be a significant rate of adverse reaction to the implanted scaffold.HypothesisThe primary hypothesis was that the implanted scaffold would not result in a deep joint infection (arthrocentesis with positive culture) or significant inflammation (clinical symptoms justifying arthrocentesis but negative culture). The secondary hypotheses were that patients treated with BEAR would have early postoperative outcomes that were similar to patients treated with ACL reconstruction with an autologous hamstring graft.Study designCohort study; Level of evidence, 2.MethodsA total of 20 patients were enrolled in this nonrandomized, first-in-human study. Ten patients received BEAR treatment and 10 received a hamstring autograft ACL reconstruction. The BEAR procedure was performed by augmenting a suture repair with a proprietary scaffold, the BEAR scaffold, placed in between the torn ends of the ACL at the time of suture repair. The BEAR scaffold is to our knowledge the only device that fills the gap between the torn ligament ends to have current Investigational Device Exemption approval from the Food and Drug Administration. Ten milliliters of autologous whole blood were added to the scaffold prior to wound closure. Outcomes were assessed at 3 months postoperatively. The outcomes measures included postoperative pain, muscle atrophy, loss of joint range of motion, and implant failure (designated by an International Knee Documentation Committee grade C or D Lachman test and/or an absence of continuous ACL tissue on magnetic resonance images).ResultsThere were no joint infections or signs of significant inflammation in either group. There were no differences between groups in effusion or pain, and no failures by Lachman examination criteria (BEAR, 8 grade A and 2 grade B; ACL reconstruction, 10 grade A). Magnetic resonance images from all of the BEAR and ACL-reconstructed patients demonstrated a continuous ACL or intact graft. In addition, hamstring strength at 3 months was significantly better in the BEAR group than in the hamstring autograft group (mean ± SD: 77.9% ± 14.6% vs 55.9% ± 7.8% of the contralateral side; P < .001).ConclusionThe results of this study suggest that the BEAR procedure may have a rate of adverse reactions low enough to warrant a study of efficacy in a larger group of patients.

Project description:BackgroundPreclinical 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).HypothesisWe 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 designRandomized controlled trial; Level of evidence, 1.MethodsOne 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.ResultsIn 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.ConclusionBEAR 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.RegistrationNCT02664545 (ClinicalTrials.gov identifier).

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).

Project description:Anterior cruciate ligament (ACL) deficiency alters 6 degrees of freedom knee kinematics, yet only anterior translation and internal rotation have been the primary measures in previous studies.To compare the 6 degrees of freedom knee kinematics and the graft forces after single- and double-bundle ACL reconstructions under various external loading conditions.Controlled laboratory study.Ten human cadaveric knees were tested with a robotic testing system under 4 conditions: intact, ACL deficient, single-bundle reconstructed with a quadrupled hamstring tendon graft, and double-bundle reconstructed with 2 looped hamstring tendon grafts. Knee kinematics and forces of the ACL or ACL graft in each knee were measured under 3 loading conditions: an anterior tibial load of 134 N, a simulated quadriceps muscle load of 400 N, and combined tibial torques (10 N.m valgus and 5 N.m internal tibial torques) at 0 degrees , 15 degrees , 30 degrees , 60 degrees , and 90 degrees of knee flexion.The double-bundle reconstruction restored the anterior and medial laxities closer to the intact knee than the single-bundle reconstruction. However, the internal rotation of the tibia under the simulated quadriceps muscle load was significantly decreased when compared with the intact knee after both reconstructions, more so after double-bundle reconstruction (P < .05). The entire graft force of the double-bundle reconstruction was more similar to that of the intact ACL than that of the single-bundle reconstruction. However, the posterolateral bundle graft in the double-bundle reconstructed knee was overloaded as compared with the intact posterolateral bundle.The double-bundle reconstruction can better restore the normal anterior-posterior and medial-lateral laxities than the single-bundle reconstruction can, but an overloading of the posterolateral bundle graft can occur in a double-bundle reconstructed knee.Both single-bundle and double-bundle techniques cannot restore the rotational laxities and the ACL force distributions of the intact knee.

Dataset Information

Bridge-Enhanced Anterior Cruciate Ligament Restoration: 6-Year Results From the First-in-Human Cohort Study.

Background

Purpose/hypothesis

Study design

Methods

Results

Conclusion

Publications

Bridge-Enhanced Anterior Cruciate Ligament Restoration: 6-Year Results From the First-in-Human Cohort Study.

Similar Datasets

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