Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessme… (NCT04361266) | Clinical Trial Compass
WithdrawnNot Applicable
Use of Nanoscaffold Augmentation in Rotator Cuff Repair: Clinical Outcome and Ultrasound Assessment of Healing Rates and Vascularity
Stopped: withdrawn
0Started 2022-08-01
Plain-language summary
The purpose is to assess Rotium, a novel nanoscaffold, impact on healing of a repaired rotator cuff and compare to a repair without Rotium. Animal (sheep) models have shown both quicker and more organized healing when Rotium is used, but there are no studies to confirm these outcomes translate to human population.
Hypothesis: Rotium rotator cuff repairs will heal both quicker and better than traditional rotator cuff repair techniques.
Who can participate
Age range
18 Years – 80 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:
* -symptomatic supraspinatus or supraspinatus and infraspinatus tear that can be repaired to the greater tuberosity in an anatomical manner using a dual layer repair technique.
* also included will be patients that have concomitant pathology addressed at time of surgery, specifically pathologies of the biceps tendon (tenodesis or tenotomy), arthrosis of the acromioclavicular joint (distal clavicle resection), or labral tearing (debridement or repair)
* included age range of subjects will be from 18-80 years old
Exclusion Criteria:
* diabetes, cancer or medical states that may impair healing, such as organ transplantation or systemic inflammatory process treated with immune modulating drugs (chemotherapy, immunosuppression drugs)
* prior surgery to the ipsilateral rotator cuff tendon
* need of soft tissue releases to accomplish an anatomic repair, partial repairs and/or concomitant subscapularis repair
* significant glenohumeral arthritis
* active or ongoing infection
* pregnancy
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.