Comparing a new graft to standard care for rotator cuff repair
Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (Active Matrix) vs. Standard of Care in Arthroscopic Rotator Cuff Repair
This study tests if a new graft can help people heal better and regain shoulder function after rotator cuff repair surgery compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05894265 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the ActiveMatrix® graft in enhancing healing and shoulder function after arthroscopic rotator cuff repair surgery. Participants with full-thickness reparable rotator cuff tears will be treated with either the ActiveMatrix® graft or standard care. The study aims to determine if the new graft leads to better outcomes compared to traditional methods. Patients will be monitored for their recovery and functional improvements over time.
Who should consider this trial
Good fit: Ideal candidates are individuals with full-thickness reparable rotator cuff tears who have not responded to conservative treatment.
Not a fit: Patients with contraindications to the treatment or those without reparable rotator cuff tears may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and function for patients undergoing rotator cuff repair.
How similar studies have performed: Other studies have shown promising results with similar graft approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Eric F Berkman, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Eric F Berkman, MD
- Email: Eric.F.Berkman@uth.tmc.edu
- Phone: 713-314-4112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.