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Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study.
Orthop J Sports Med 2019; 7(3):2325967118824356OJ

Abstract

Background

Bridge-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/Hypothesis

The 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 Design

Cohort study; Level of evidence, 2.

Methods

Ten 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.

Results

There 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).

Conclusion

In 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.

Authors+Show Affiliations

Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.No affiliation info availableInvestigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.Investigation performed at Boston Children's Hospital, Boston, Massachusetts, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30923725

Citation

Murray, Martha M., et al. "Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study." Orthopaedic Journal of Sports Medicine, vol. 7, no. 3, 2019, p. 2325967118824356.
Murray MM, Kalish LA, Fleming BC, et al. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Orthop J Sports Med. 2019;7(3):2325967118824356.
Murray, M. M., Kalish, L. A., Fleming, B. C., Flutie, B., Freiberger, C., Henderson, R. N., ... Micheli, L. J. (2019). Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Orthopaedic Journal of Sports Medicine, 7(3), p. 2325967118824356. doi:10.1177/2325967118824356.
Murray MM, et al. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Orthop J Sports Med. 2019;7(3):2325967118824356. PubMed PMID: 30923725.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. AU - Murray,Martha M, AU - Kalish,Leslie A, AU - Fleming,Braden C, AU - ,, AU - Flutie,Brett, AU - Freiberger,Christina, AU - Henderson,Rachael N, AU - Perrone,Gabriel S, AU - Thurber,Laura G, AU - Proffen,Benedikt L, AU - Ecklund,Kirsten, AU - Kramer,Dennis E, AU - Yen,Yi-Meng, AU - Micheli,Lyle J, Y1 - 2019/03/22/ PY - 2019/3/30/entrez PY - 2019/3/30/pubmed PY - 2019/3/30/medline KW - ACL reconstruction KW - ACL repair KW - BEAR KW - anterior cruciate ligament KW - bridge-enhanced ACL repair KW - human SP - 2325967118824356 EP - 2325967118824356 JF - Orthopaedic journal of sports medicine JO - Orthop J Sports Med VL - 7 IS - 3 N2 - Background: Bridge-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/Hypothesis: The 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 Design: Cohort study; Level of evidence, 2. Methods: Ten 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. Results: There 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). Conclusion: In 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. SN - 2325-9671 UR - https://www.unboundmedicine.com/medline/citation/30923725/Bridge-Enhanced_Anterior_Cruciate_Ligament_Repair:_Two-Year_Results_of_a_First-in-Human_Study L2 - http://journals.sagepub.com/doi/full/10.1177/2325967118824356?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -