The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study

Martha M Murray, Brett M Flutie, Leslie A Kalish, Kirsten Ecklund, Braden C Fleming, Benedikt L Proffen, Lyle J Micheli, Martha M Murray, Brett M Flutie, Leslie A Kalish, Kirsten Ecklund, Braden C Fleming, Benedikt L Proffen, Lyle J Micheli

Abstract

Background: This 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.

Hypothesis: The 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 design: Cohort study; Level of evidence, 2.

Methods: A 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).

Results: There 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).

Conclusion: The 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.

Keywords: ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human.

Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: Funding for this study was provided by the Translational Research Program at Boston Children’s Hospital, the Children’s Hospital Orthopaedic Surgery Foundation, the Children’s Hospital Sports Medicine Foundation as well as the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grant numbers R01-AR065462 and R01-AR056834. This work also was conducted with the additional support of the National Football League Players Association (NFLPA). M.M.M. is an inventor on patents held by Boston Children’s Hospital regarding the use of collagen materials to stimulate ligament repair.

Figures

Figure 1.
Figure 1.
CONSORT 2010 flow diagram. *The total number of patients not meeting inclusion criteria totals to greater than 214, as some patients met more than 1 exclusion criterion. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair.
Figure 2.
Figure 2.
Stepwise demonstration of the bridge-enhanced ACL repair (BEAR) technique using the BEAR scaffold. (A) In this technique, the torn ACL tissue is preserved. (B) A whipstitch using No. 2 Vicryl (purple) is placed into the tibial stump of the ACL. Small tunnels (4 mm) are drilled in the femur and tibia, and an Endobutton with two No. 2 Ethibond sutures (green) and the No. 2 Vicryl ACL sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. The Ethibond sutures are threaded through the BEAR scaffold, tibial tunnel, and secured in place with an extracortical button. The BEAR scaffold is then saturated with 10 mL of the patient’s blood, and (C) the tibial stump pulled up into the saturated scaffold. (D) The ends of the torn ACL then grow into the BEAR scaffold and the ligament reunites. ACL, anterior cruciate ligament.
Figure 3.
Figure 3.
Preoperative magnetic resonance appearance of the injured anterior cruciate ligament (ACL) in the 10 patients in the bridge-enhanced ACL repair (BEAR) cohort.
Figure 4.
Figure 4.
Preoperative magnetic resonance appearance of the injured anterior cruciate ligament (ACL) in the 10 patients in the ACL reconstruction cohort.
Figure 5.
Figure 5.
Sagittal proton density (intermediate-weighted) images from all 10 subjects in the bridge-enhanced ACL repair (BEAR) group at 3 months after surgery show intact ACL fibers from the femoral to the tibial attachment sites (arrows). The intact fibers are low signal intensity (black), reflecting highly organized tissue with little free water. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. ACL, anterior cruciate ligament.
Figure 6.
Figure 6.
Sagittal proton density (intermediate-weighted) images from all 10 subjects in the hamstring autograft reconstruction group at 3 months after surgery show intact graft from the femoral to the tibial tunnels (arrows). The signal intensity within the graft is variable. The homogeneous low signal intensity (black) in some subjects (eg, top row second from left and bottom row third from left) is typical of the normal in situ hamstring tendon due to highly organized connective tissue with little free water. A more heterogeneous appearance is present in several subjects (eg, top row fourth from left) with central low signal tendon and peripheral high signal (lighter gray) indicating surrounding edema. Other subjects show intrasubstance higher signal within the graft itself (eg, bottom right) reflecting increased fluid within the graft.

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Source: PubMed

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