Prospective Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft Active Matrix (AM) vs. Standard of Care in Arthroscopic Rotator Cuff Repair

Exclusion Criteria16

• Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
• Prior surgery for bone defects requiring bone implantation in the index shoulder,
• Steroid injection into the index shoulder within 6 weeks of enrollment.
• Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
• Calcific tendonitis in the index shoulder,
• Fatty infiltration of the index shoulder rotator cuff muscle, i.e. Goutallier classification ≥ Grade 3,
• Contralateral shoulder injury that may interfere with the post-operative rotator cuff repair rehab guidelines,
• History of advanced osteoarthritis of glenohumeral joint (AC joint can have advanced OA) i.e. Samilson-Prieto classification ≥ Grade 2
• History of malignant tumor and osseous metastatic disease,
• History of heterotopic ossification,
• History of chronic pain disorders (i.e., fibromyalgia),
• Current substance abuse (drug or alcohol), by the investigator's judgment,
• For females of child-bearing potential: unable or unwilling to take adequate contraceptive precautions during the study, known to be pregnant at enrollment, breastfeeding an infant at enrollment or during the study, or planning to become pregnant during the study,
• Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,
• Currently involved in any injury litigation or workers compensation claims,
• has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.