The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Exper… (NCT07689383) | Clinical Trial Compass
CompletedPhase 2
The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study
Greece51 participantsStarted 2021-11-20
Plain-language summary
Purpose of the study:
The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear.
What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.
Who can participate
Age range
18 Years – 79 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:
The patients enrolled had symptomatic rotator cuff tears, which were confirmed by magnetic resonance imaging (MRI). They had failed previous conservative management and physical therapy of at least 3 months and were candidates for surgical treatment.
Exclusion Criteria:
a) acute shoulder trauma, (b) any history of a previous surgical operation on their shoulder, (c) the local administration of corticosteroids up to fifteen days before the operation or systemic administration of corticosteroids up to a month before the operation, (d) the use of non-steroidal anti-inflammatory drugs during the trial, (e) any signs of infection or systematic inflammatory disease for at least fifteen days before the operation, (f) history of malignancy or chemotherapy during the previous year, (g) rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head, (h) pregnancy or breastfeeding, and in case of any of these conditions the patients where ultimately excluded from the trial results.
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.