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Tests treatment safety and results for Rotator Cuff Injuries
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
ClinicalTrials.gov ID: NCT07348016
What this study is testing
What is Liposomal Bupivacaine + Compound Betamethasone Injection?
Liposomal Bupivacaine + Compound Betamethasone Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for rotator cuff injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Scheduled for arthroscopic rotator cuff repair and capsular release.
- Willing and able to provide written informed consent.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.