A Prospective Double Blinded Randomized Controlled Trial Examining the Effectiveness of a Connective Tissue Matrix Implant in Reducing Post-operative Pain and Narcotic Use in Patients Under 55yo After Outpatient Arthroscopic Shoulder Surgery

Shoulder surgery has evolved over the past decade with many procedures now done on an outpatient basis. Multimodal pain management strategies and regional anesthesia have greatly contributed to this transition and newer strategies continue to evolve. Uncontrolled pain can often lead to readmissions, prolonged hospital or ambulatory stays and an overall negative patient experience. Despite improvements in regional anesthetic technique and newer longer acting medicines such as liposomal bupivacaine, the duration of pain relief is often only over the course of 72 hours postoperatively. Post-operative pain beyond 72 hours is largely inflammatory in nature. As such, biologic approaches to reduce surgical tissue damage-induced inflammation is an attractive therapeutic addition to surgical procedures. These approaches are especially relevant in light of the current opioid epidemic plaguing the United States.

Flowable, placental-derived connective tissue matrix (pECM) is a potential option to supplement damaged tissue prone to inflammation as it introduces nascent, hydrated components of the inflammatory phase, including structural proteins and growth factors, which allow for efficient repair. Derived from relatively immune-privileged tissue, placental-derived pECM elicits little or no immune response in recipients. They have been shown to greatly reduce inflammatory cell influx and inflammatory cytokines present in dermal and mucosal surgical sites post-operatively. Moreover, placental-derived pECM reduces expression of prostaglandin E2, a potent pain mediator, in vitro. In the orthopedic space, ECM has been used effectively to reduce pain following spinal fusion and for treatment of knee arthritis. Taken together, biologic therapies directed at modulating inflammation and associated pain is an increasing area of interest with far reaching implications.

The purpose of the current study is to prospectively analyze two groups of patients treated for arthroscopic shoulder surgery with and without a flowable pECM to determine if a significant reduction in pain and opioid consumption as measured in morphine equivalent units is demonstrated within the first 6 weeks of surgery. Furthermore, patients will be compared in regard to early range of motion and patient reported outcomes to determine if a difference is present when the ECM is utilized within the first 6 months of surgery. This is the first double blinded prospective series in the shoulder literature to date looking at a pECM graft for pain reduction and improved range of motion perioperatively.

Study Objectives

Utilizing a prospective randomized controlled trial, the aim of this study is to assess modulation of post-operative pain and narcotic use when a placental-derived extracellular matrix is injected into the bed of the repair following outpatient arthroscopic shoulder surgery. Furthermore, this study aims to determine if the addition of pECM influences patient reported outcomes and influences early postoperative range of motion.