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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · May 30, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option called the ActiveMatrix® graft for patients undergoing surgery to repair rotator cuff tears in the shoulder. The goal is to determine how well this graft helps the shoulder heal and improves its function after surgery compared to standard care. The study is currently looking for participants aged 27 to 74 who have a full-thickness tear of the rotator cuff and have not found relief through physical therapy or other treatments for at least four to six weeks. Participants should also be willing to follow the study's procedures and attend all required follow-up visits.

If you decide to join the study, you will receive the ActiveMatrix® graft during your shoulder surgery and will be monitored closely to see how well your shoulder heals over time. It's important to note that there are specific criteria for joining, such as not having had recent shoulder surgery or certain shoulder injuries that could complicate the study. This trial aims to provide valuable information that could improve future treatments for rotator cuff injuries, so participating could help both you and others facing similar shoulder issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of signed and dated informed consent form
• • Stated willingness to comply with all study procedures and availability for the duration of the study
• • 1-2 tendon full thickness reparable rotator cuff tendon tear(s)
• Reparable tear defined as:
• • a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension.
• Full-thickness tear defined as:
• • a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border
• • Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
• • Have no contraindications or allergies to the treatment administered
• • Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses
• • Able and willing to comply with the post-operative physical therapy and study follow-up schedule
• Exclusion Criteria:
• • 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.