Neuromuscular response to competing ACL surgeries

Rhode Island Hospital, Providence RI

Investigators

Linked publications & trials

Abstract

ABSTRACT The objective of the parent ancillary project is to leverage patients enrolled in the BEAR-MOON Trial to determine whether bridge-enhanced anterior cruciate ligament (ACL) restoration (BEAR) conserves neuromuscular and kinematic function better than the standard of care, ACL reconstruction. The objective of the proposed supplement is to augment the generalizability and statistical power of the ancillary project by recruiting BEAR-MOON Trial patients from a second Trial site based in Minnesota. Whereas ACLR requires removal of the injured ligament and the bony insertion sites to implant a tendon graft, BEAR uses a scaffold to promote healing of the injured ACL. Therefore, the ACL neural structures and bony insertions remain intact with BEAR, while they are severed and removed during ACLR. Early clinical studies have shown that muscle strength is restored following BEAR, but not after ACLR at 2-year follow-up. The parent ancillary study posits that differences in muscle recovery and joint motion are due to the preservation of neuromuscular function with BEAR. Thus, the BEAR-MOON Trial will tell us if clinical outcomes between the competing surgeries are different, while the ancillary study provides insight as to why they may be different by testing the hypothesis that BEAR preserves the neuromuscular activation patterns about the knee which, in turn, promote normal hop landing joint motion compared to ACLR. The ancillary study aims are to: 1) Apply our machine learning approach to classify neuromuscular activity patterns as belonging to ACLR, BEAR or healthy control subjects (Controls); 2) Compare knee position between ACLR, BEAR, and Control subjects at ground contact when landing from a 1-leg hop; and 3) Determine the relationship between neuromuscular activity patterns and joint motion abnormalities. The parent ancillary project is enrolling 26 BEAR-MOON Trial patients (13 BEAR patients; 13 ACLR patients) at the Rhode Island Hospital site following their final Trial 2-year visit. Thirteen control subjects matched to the Rhode Island Hospital Trial site demographics will additionally be enrolled. For this supplement we propose to enroll an additional 14 TRIA/University of Minnesota BEAR-MOON Trial patients (7 BEAR patients; 7 ACLR patients) and 7 healthy Controls matched proportionally to the TRIA/University of Minnesota site Trial demographics. All procedures will follow the IRB-approved parent ancillary study. Enrolling BEAR-MOON Trial patients from the TRIA/University of Minnesota site will augment the generalizability of our findings, increase the statistical power of the ancillary study, and guarantee that we will complete BEAR-MOON subject ancillary study enrollment should patient recruitment prove difficult due to parent Trial patient attrition at the single site at 2-year follow-up. The outcomes of the parent ancillary study will provide high quality evidence to further assist clinicians and patients in surgical decision making.