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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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  • معلومة اضافية
    • Author-Supplied Keywords:
      ACL reconstruction
      ACL repair
      anterior cruciate ligament
      BEAR
      bridge-enhanced ACL repair
      human
      scaffold-enhanced ACL repair
    • NAICS/Industry Codes:
      541910 Marketing Research and Public Opinion Polling
      339113 Surgical Appliance and Supplies Manufacturing
    • 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) [ABSTRACT FROM AUTHOR]
    • Abstract:
      Copyright of American Journal of Sports Medicine is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
    • Author Affiliations:
      1Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA
    • Full Text Word Count:
      8111
    • ISSN:
      0363-5465
    • Accession Number:
      10.1177/0363546520913532
    • Accession Number:
      143230945
  • Citations
    • ABNT:
      MURRAY, M. M. et al. 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. American Journal of Sports Medicine, [s. l.], v. 48, n. 6, p. 1305–1315, 2020. DOI 10.1177/0363546520913532. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=143230945&custid=s8280428. Acesso em: 11 jul. 2020.
    • AMA:
      Murray MM, Fleming BC, Badger GJ, et al. 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. American Journal of Sports Medicine. 2020;48(6):1305-1315. doi:10.1177/0363546520913532.
    • AMA11:
      Murray MM, Fleming BC, Badger GJ, et al. 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. American Journal of Sports Medicine. 2020;48(6):1305-1315. doi:10.1177/0363546520913532
    • APA:
      Murray, M. M., Fleming, B. C., Badger, G. J., Freiberger, C., Henderson, R., Barnett, S., Kiapour, A., Ecklund, K., Proffen, B., Sant, N., Kramer, D. E., Micheli, L. J., & Yen, Y.-M. (2020). 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. American Journal of Sports Medicine, 48(6), 1305–1315. https://doi.org/10.1177/0363546520913532
    • Chicago/Turabian: Author-Date:
      Murray, Martha M., Braden C. Fleming, Gary J. Badger, Christina Freiberger, Rachael Henderson, Samuel Barnett, Ata Kiapour, et al. 2020. “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.” American Journal of Sports Medicine 48 (6): 1305–15. doi:10.1177/0363546520913532.
    • Harvard:
      Murray, M. M. et al. (2020) ‘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’, American Journal of Sports Medicine, 48(6), pp. 1305–1315. doi: 10.1177/0363546520913532.
    • Harvard: Australian:
      Murray, MM, Fleming, BC, Badger, GJ, Freiberger, C, Henderson, R, Barnett, S, Kiapour, A, Ecklund, K, Proffen, B, Sant, N, Kramer, DE, Micheli, LJ & Yen, Y-M 2020, ‘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’, American Journal of Sports Medicine, vol. 48, no. 6, pp. 1305–1315, viewed 11 July 2020, .
    • MLA:
      Murray, Martha M., et al. “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.” American Journal of Sports Medicine, vol. 48, no. 6, May 2020, pp. 1305–1315. EBSCOhost, doi:10.1177/0363546520913532.
    • Chicago/Turabian: Humanities:
      Murray, Martha M., Braden C. Fleming, Gary J. Badger, Christina Freiberger, Rachael Henderson, Samuel Barnett, Ata Kiapour, et al. “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.” American Journal of Sports Medicine 48, no. 6 (May 2020): 1305–15. doi:10.1177/0363546520913532.
    • Vancouver/ICMJE:
      Murray MM, Fleming BC, Badger GJ, Freiberger C, Henderson R, Barnett S, et al. 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. American Journal of Sports Medicine [Internet]. 2020 May [cited 2020 Jul 11];48(6):1305–15. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=143230945&custid=s8280428