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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

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          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)

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          Most cited references52

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          Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture

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            Allograft Versus Autograft Anterior Cruciate Ligament Reconstruction

            Background: Tearing an anterior cruciate ligament (ACL) graft is a devastating occurrence after ACL reconstruction (ACLR). Identifying and understanding the independent predictors of ACLR graft failure is important for surgical planning, patient counseling, and efforts to decrease the risk of graft failure. Hypothesis: Patient and surgical variables will predict graft failure after ACLR. Study Design: Prospective cohort study. Methods: A multicenter group initiated a cohort study in 2002 to identify predictors of ACLR outcomes, including graft failure. First, to control for confounders, a single surgeon’s data (n = 281 ACLRs) were used to develop a multivariable regression model for ACLR graft failure. Evaluated variables were graft type (autograft vs allograft), sex, age, body mass index, activity at index injury, presence of a meniscus tear, and primary versus revision reconstruction. Second, the model was validated with the rest of the multicenter study’s data (n = 645 ACLRs) to evaluate the generalizability of the model. Results: Patient age and ACL graft type were significant predictors of graft failure for all study surgeons. Patients in the age group of 10 to 19 years had the highest percentage of graft failures. The odds of graft rupture with an allograft reconstruction are 4 times higher than those of autograft reconstructions. For each 10-year decrease in age, the odds of graft rupture increase 2.3 times. Conclusion: There is an increased risk of ACL graft rupture in patients who have undergone allograft reconstruction. Younger patients also have an increased risk of ACL graft failure. Clinical Relevance: Given these risks for ACL graft rupture, allograft ACLRs should be performed with caution in the younger patient population.
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              The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data.

              The International Knee Documentation Committee Subjective Knee Evaluation Form may be used to measure symptoms, function, and sports activity for people with a variety of knee disorders, including ligamentous and meniscal injuries, osteoarthritis, and patellofemoral dysfunction. To date, normative data have not been established for this valid, reliable, and responsive outcomes instrument. To provide clinicians and researchers with normative data to facilitate the interpretation of results on the International Knee Documentation Committee Subjective Knee Evaluation Form. Cross-sectional survey. The Subjective Knee Evaluation Form was mailed to 600 people in each of 8 age/gender categories (18-24 years, 25-34 years, 35-50 years, and 51-65 years for both male subjects and female subjects). Participants were drawn from a panel of 550 000 households (1 300 000 subjects) representative of noninstitutionalized persons in the United States and were matched to data from the United States Census Bureau on geographical region, market size, income, and household size. Complete data were available for 5246 knees. Twenty-eight percent of respondents reported an injury, weakness, or other problem with one or both knees. Normative data were determined for respondents as a whole and for the subset of respondents with no history of knee problems. Mean scores were determined for men aged 18 to 24 years (89 +/- 18), 25 to 34 years (89 +/- 16), 35 to 50 years (85 +/- 19), and 51 to 55 years (77 +/- 23); mean scores were also determined for women aged 18 to 24 years (86 +/- 19), 25 to 34 years (86 +/- 19), 35 to 50 years (80 +/- 23), and 51 to 65 years (71 +/- 26). Scores were higher for the subset of respondents with no history of current or prior knee problems. Scores on the International Knee Documentation Committee Subjective Knee Evaluation Form vary by age, gender, and history of knee problems. The normative data collected in this article will allow clinicians to interpret how patients with knee injuries are functioning relative to their age- and gender-matched peers and will enable researchers to determine the clinical outcomes of treatment.
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                Author and article information

                Journal
                Am J Sports Med
                Am J Sports Med
                AJS
                amjsports
                The American Journal of Sports Medicine
                SAGE Publications (Sage CA: Los Angeles, CA )
                0363-5465
                1552-3365
                16 April 2020
                May 2020
                : 48
                : 6
                : 1305-1315
                Affiliations
                [1-0363546520913532]Investigation performed at Boston Children’s Hospital, Boston, Massachusetts, USA
                Author notes
                [*] [* ]Martha M. Murray, MD, Division of Sports Medicine, Department of Orthopaedic Surgery, Boston Children’s Hospital, 300 Longwood Ave, Hunnewell 2, Boston, MA 02115, USA (email: bear.trial@ 123456childrens.harvard.edu ).
                Article
                10.1177_0363546520913532
                10.1177/0363546520913532
                7227128
                32298131
                d596463e-0a50-4701-80cf-a50edaed768e
                © 2020 The Author(s)

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License ( https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 12 October 2019
                : 6 February 2020
                Categories
                Articles
                Knee
                Custom metadata
                ts1

                anterior cruciate ligament,human,acl reconstruction,acl repair,bridge-enhanced acl repair,scaffold-enhanced acl repair,bear

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