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
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 forward flexion less than 100�b0 and/or external rotation less than 10�b0
- 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 such as rheumatoid arthritis
- Coagulation disorders or use of anticoagulants that cannot be safely stopped around surgery
- Pregnancy or lactation
- Participation in another clinical trial within the past 3 months
- Any medical or psychiatric condition that could compromise safety or study compliance according to the investigator
AI-Screening
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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
CONTACT
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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