Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic … (NCT07348016) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial
China70 participantsStarted 2025-08-01
Plain-language summary
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes.
Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment.
What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI.
Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).
Who can participate
Age range
18 Years – 70 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:
Age between 18 and 70 years.
Clinical and MRI diagnosis of full-thickness rotator cuff tear.
Presence of shoulder stiffness/adhesion defined as passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation (or according to your specific definition).
Scheduled for arthroscopic rotator cuff repair and capsular release.
Willing and able to provide written informed consent.
Willing to comply with all study procedures and follow-up visits.
Exclusion Criteria :
Massive, irreparable rotator cuff tear.
Severe glenohumeral osteoarthritis (Grade III or IV according to Samilson-Prieto classification).
History of shoulder infection, fracture, or previous surgery on the affected shoulder.
Known allergy or contraindication to betamethasone, local anesthetics, or components of PRP preparation.
Systemic inflammatory arthritis (e.g., rheumatoid arthritis).
Coagulation disorders or use of anticoagulants that cannot be safely suspended perioperatively.
Pregnancy or lactation.
Participation in another clinical trial within the past 3 months.
Any medical or psychiatric condition that, in the investigator's opinion, would compromise patient safety or compliance with the study protocol.
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.
1This trial combines platelet-rich plasma with compound betamethasone during arthroscopic surgery — can you explain what each of those treatments does and why using them together might matter for my specific type of rotator cuff injury with shoulder adhesion?
2The trial is listed as Phase NA, which I understand may mean it's a procedure-based or device study rather than a traditional drug trial — what does that mean for how much is already known about the safety of this combined approach, and what risks should I be aware of?
3The trial measures shoulder function using the Constant-Murley Score and pain at rest using a VAS scale — how would my current scores on those measures compare to what they'd be looking for in eligible participants, and would I be a good fit to discuss with the study team?
4Since this is a multicenter randomized controlled trial, there's a chance I could be assigned to a control group — can you walk me through what treatment I would receive if I'm not in the group getting both PRP and betamethasone, and how that compares to standard care you'd recommend for me outside of this trial?
5Before considering this trial, are there standard non-surgical or surgical treatments for my rotator cuff injury and shoulder adhesion that I should try first, or is my condition at a point where this trial's approach might be worth exploring sooner?
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
Change in Constant-Murley Shoulder Score
Timeframe: Baseline, 3 months, and 12 months postoperatively.
2
Visual Analog Scale (VAS) Pain Score at Rest
Timeframe: Baseline, 3 months, and 12 months postoperatively.
Trial details
NCT IDNCT07348016
SponsorSecond Affiliated Hospital of Nanchang University