Actively Recruiting
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
Led by Second Affiliated Hospital of Nanchang University · Updated on 2026-01-16
70
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on adults with full-thickness rotator cuff tears and shoulder stiffness undergoing arthroscopic surgery. It aims to evaluate whether adding a long-acting local anesthetic, Liposomal Bupivacaine, to a standard steroid injection, Compound Betamethasone, can improve pain, shoulder function, and tendon healing after surgery. The study is a prospective, randomized, double-blind trial involving approximately 70 patients to compare these treatments. Participants are randomly assigned to one of two groups. Both groups undergo arthroscopic rotator cuff repair and shoulder adhesion release. One group receives an injection combining Liposomal Bupivacaine and Compound Betamethasone, while the other group receives Compound Betamethasone alone after surgery. The injections are given directly into the shoulder joint under arthroscopic guidance. The study includes a 12-month follow-up period with assessments at various times. During the study, participants will have their pain levels, shoulder function, range of motion, and tendon healing monitored using tools like the UCLA Shoulder Score, Constant-Murley Score, Visual Analog Scale for pain, and MRI scans. Safety is monitored through tracking complications such as infection, re-tear, and thrombosis. Assessments occur from before surgery up to 12 months afterward to compare outcomes and safety between the two treatment groups.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years.
- Clinical and MRI diagnosis of full-thickness rotator cuff tear.
- Presence of shoulder stiffness or adhesion with passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation.
- 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.
You will not qualify if you...
- 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 would compromise patient safety or study compliance.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of either Liposomal Bupivacaine combined with Compound Betamethasone or Compound Betamethasone alone.
1 surgical visit (in-person)
Duration - Up to 12 months postoperatively
Participants are monitored for recovery, tendon healing, shoulder function, pain, and potential adverse events after surgery and injection.
Visits at baseline, 3 months, 6 months, and 12 months postoperatively
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
Research Team
H
Hao Liang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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