Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial

Ryan M Sanborn, Gary J Badger, BEAR Trial Team, Yi-Meng Yen, Martha M Murray, Melissa A Christino, Benedikt Proffen, Nicholas Sant, Samuel Barnett, Braden C Fleming, Dennis E Kramer, Lyle J Micheli, Ryan M Sanborn, Gary J Badger, BEAR Trial Team, Yi-Meng Yen, Martha M Murray, Melissa A Christino, Benedikt Proffen, Nicholas Sant, Samuel Barnett, Braden C Fleming, Dennis E Kramer, Lyle J Micheli

Abstract

Background: Previous clinical studies have shown that psychological factors have significant effects on an athlete's readiness to return to sport after anterior cruciate ligament (ACL) reconstruction (ACLR).

Hypothesis: We hypothesized that patients who underwent bridge-enhanced ACL restoration (BEAR) would have higher levels of psychological readiness to return to sport compared with patients who underwent ACLR.

Study design: Randomized controlled trial; Level of evidence, 1.

Methods: A total of 100 patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were randomized to either the BEAR procedure (n = 65) or autograft ACLR (n = 35 [33 hamstring and 2 bone--patellar tendon-bone]) and underwent surgery within 45 days of injury. Objective, functional, and patient-reported outcomes, including the ACL--Return to Sport after Injury (ACL-RSI) scale, were assessed at 6, 12, and 24 months postoperatively.

Results: Patients who underwent the BEAR procedure had significantly higher ACL-RSI scores at 6 months compared with those who underwent ACLR (71.1 vs 58.2; P = .008); scores were similar at 12 and 24 months. Baseline factors independently predictive of higher ACL-RSI scores at 6 months were having a BEAR procedure and participating in level 1 sports prior to injury, explaining 15% of the variability in the scores. Regression analysis of baseline and 6-month outcomes as predictors indicated that the International Knee Documentation Committee (IKDC) score at 6 months explained 45% of the 6-month ACL-RSI variance. Subsequent analysis with IKDC excluded from the model indicated that decreased pain, increased hamstring and quadriceps strength in the surgical limb, and decreased side-to-side difference in anteroposterior knee laxity were significant predictors of a higher ACL-RSI score at 6 months, explaining 34% of the variability in scores. Higher ACL-RSI score at 6 months was associated with earlier clearance to return to sports.

Conclusion: Patients who underwent the BEAR procedure had higher ACL-RSI scores at 6 months postoperatively. Better ACL-RSI scores at 6 months were related most strongly to higher IKDC scores at 6 months and were also associated with lower pain levels, better muscle recovery, and less knee laxity at 6 months.

Registration: NCT02664545 (ClinicalTrials.gov identifier).

Keywords: ACL reconstruction; ACL-RSI; BEAR; anterior cruciate ligament; bridge-enhanced ACL restoration; psychological readiness; return to sport.

Conflict of interest statement

One or more of the authors has declared the following potential conflict of interest or source of funding: This study received funding support from the Translational Research Program at Boston Children’s Hospital, the Children’s Hospital Orthopaedic Surgery Foundation, the Children’s Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, the National Institutes of Health, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants R01-AR065462 and R01-AR056834. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University or its affiliated academic health care centers, the National Football League Players Association, Boston Children’s Hospital, or the National Institutes of Health. Y.-M.Y. has received education payments from Kairos Surgical and consulting fees from Smith & Nephew. M.M.M. is a founder, paid consultant, and equity holder in Miach Orthopaedics, which was formed to work on upscaling production of the BEAR scaffold. M.M.M. has also received honoraria from Musculoskeletal Transplant Foundation. M.A.C. has received hospitality payments from Smith & Nephew. B.P. has received consulting fees and has stock/stock options in Miach Orthopaedics. N.S. has received consulting fees from Miach Orthopaedics. B.C.F. is a paid associate editor for The American Journal of Sports Medicine and is the spouse of M.M.M. with inherently the same conflicts. D.E.K. has received education payments from Kairos Surgical. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.

© The Author(s) 2022.

Figures

Figure 1.
Figure 1.
CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study. ACL, anterior cruciate ligament; ACLR, ACL reconstruction; BEAR, bridge-enhanced ACL restoration; BPTB, bone--patellar tendon–bone; KT, KT-1000 arthrometer testing; M, months; RSI, ACL--Return to Sport after Injury.
Figure 2.
Figure 2.
Mean ACL-RSI scores for BEAR and ACLR groups at 6, 12, and 24 months postoperatively. *P < .05. ACL, anterior cruciate ligament; ACLR, ACL reconstruction; BEAR, bridge-enhanced ACL restoration; ACL-RSI, ACL--Return to Sport after Injury.
Figure 3.
Figure 3.
Plot for time to clearance for return to sports based on a cutoff ACL-RSI score of 65 at 6 months after surgery. ACL, anterior cruciate ligament; ACL-RSI, ACL--Return to Sport after Injury.

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Source: PubMed

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