An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction (NCT04615117) | Clinical Trial Compass
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An Outcomes Study Utilizing Allomend(R) HD for Superior Capsular Reconstruction
United States25 participantsStarted 2021-08-01
Plain-language summary
Rotator cuff tears can usually be repaired with excellent results, however some chronic, extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity, muscle atrophy, and fatty infiltration. Arthroscopic superior capsular reconstruction (SCR) utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears. Grafts utilized for SCR have included fascia lata, hamstring autograft, human acellular dermal tissue matrix (HADTM), and acellular porcine dermal xenograft. Due to donor morbidity associated with autografts and the graft rejection potential of xenograft, HADTM has become a common graft of choice for SCR. The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acromiohumeral interval change
Timeframe: 24 months
2
Clinical Failure
Timeframe: Within 24 months
3
Rotator Cuff Integrity and Graft Incorporation
Timeframe: 24 months
Trial details
NCT IDNCT04615117
SponsorWestern Orthopaedics Research and Education Foundation