CompletedNot Applicable

Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot

United States53 participantsStarted 2019-03-01

Plain-language summary

The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.

Who can participate

Age range

18 Years – 69 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: 1\) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (\> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts \>150,000/microliter. Exclusion Criteria: 1\) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age \>70.

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

Vascularity Index

Timeframe: Assessed 6 weeks postoperatively.

Trial details

NCT IDNCT03577379

SponsorSanta Barbara Cottage Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-25

View on ClinicalTrials.gov More Rotator Cuff Tear trials