Using Allomend for shoulder surgery in patients with severe rotator cuff tears
An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
This study is testing whether using AlloMend for shoulder surgery can help people with severe rotator cuff tears feel better and improve their shoulder function compared to regular grafts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Orthopaedics Research and Education Foundation Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT04615117 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical and anatomical outcomes of patients undergoing superior capsular reconstruction (SCR) using AlloMend allograft for irreparable rotator cuff tears. The study will assess improvements in shoulder stability and function through pre-operative MRI and post-operative evaluations. By focusing on patients with chronic, extensive rotator cuff injuries, the research seeks to determine the effectiveness of AlloMend compared to traditional graft options. The outcomes will include radiographic, clinical, and patient-reported measures to gauge success.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing SCR for massive rotator cuff tears and have specific pre-operative strength and MRI criteria.
Not a fit: Patients with significant cognitive disabilities, contraindications to MRI, or certain shoulder dysfunctions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve shoulder function and quality of life for patients with irreparable rotator cuff tears.
How similar studies have performed: Previous studies have shown promising results with similar graft approaches, but the use of AlloMend specifically is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who are undergoing SCR for massive rotator cuff * Adult patients (≥18) * Pre-operative MRI obtained within 26 weeks prior to surgery * Must have 3 out of 5 external rotation strength * Must have intact teres minor Exclusion Criteria: * Worker's Compensation Case * Persons with a mental or cognitive disability deemed significant enough that they would not be capable of complying with a restricted rehabilitation program or completing the outcome measures * Patients with known contraindications to MRI * Pectoralis major, pectoralis minor, deltoid, or latissimus dorsi dysfunction * Acute fractures of humerus, clavicle, scapula * Inability to speak and/or understand English Intra-Op Exclusion Criteria: * Anterosuperior escape of the glenohumeral joint due to a completely incompetent anterosuperior cuff and coracoacromial ligament (CAL) * Unable to fix the graft on the humeral side utilizing a double row repair * Inability to address subscapularis pathology * Diffuse bipolar cartilage loss
Where this trial is running
Denver, Colorado
- Western Orthopaedics Education and Research Foundation — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Armodios Hatzidakis, MD — Western Orthopaedics Education and Research Foundation
- Study coordinator: Jackie Bader, MS
- Email: JBader@western-ortho.com
- Phone: 303-321-1333
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.