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
Second Affiliated Hospital of Nanchang University
70 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
Intra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures.
Intra-articular injection of Compound Betamethasone alone under arthroscopic guidance after standard surgical procedures.
Locations(1)
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NCT07348016