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โ† Trials
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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

RecruitingNAAges 18 Years - 70 YearsAllSecond Affiliated Hospital of Nanchang University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 100ยฐ in forward flexion and/or less than 10ยฐ 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.
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What it tests

  • Liposomal Bupivacaine + Compound Betamethasone Injection
  • Compound Betamethasone Injection
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Where

1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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