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

NCT07348016 | Recruiting

• 1 other identifier: EFY-2025-085
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adhesions; Rotator Cuff Injuries

Keywords

Platelet-Rich Plasma; Compound Betamethasone; Arthroscopy; Randomized Controlled Trial; Shoulder; Stiffness

Outcome Measures

Primary Outcomes (2)

• Change in Constant-Murley Shoulder Score

  The Constant-Murley score is a composite outcome measure assessing shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better function.

  Baseline, 3 months, and 12 months postoperatively.

• Visual Analog Scale (VAS) Pain Score at Rest

  Pain intensity at rest measured on a 100-mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable."

  Baseline, 3 months, and 12 months postoperatively.

Secondary Outcomes (4)

• Active Range of Motion (ROM)

  Baseline, 3 months, and 12 months postoperatively.

• American Shoulder and Elbow Surgeons (ASES) Score

  Baseline, 3 months, and 12 months postoperatively.

• MRI Assessment of Tendon Healing

  3 months and 12 months postoperatively.

• Incidence of Treatment-Related Adverse Events

  From the time of surgery up to 12 months postoperatively.

Study Arms (2)

Combination Therapy Group

EXPERIMENTAL

Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone.

Drug: Liposomal Bupivacaine + Compound Betamethasone Injection

Monotherapy (Control) Group

ACTIVE COMPARATOR

Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone.

Drug: Compound Betamethasone Injection

Interventions

Compound Betamethasone Injection DRUG

Intra-articular injection of Compound Betamethasone alone under arthroscopic guidance after standard surgical procedures.

Monotherapy (Control) Group

Liposomal Bupivacaine + Compound Betamethasone Injection DRUG

Intra-articular injection of a mixture containing Liposomal Bupivacaine and Compound Betamethasone under arthroscopic guidance after standard surgical procedures.

Combination Therapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Tissue Adhesions

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hao Liang, MD

CONTACT

+86-13607008562; haoliang201@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The injection syringes will be prepared by a research pharmacist or designated staff member not involved in patient assessment. Both the experimental (PRP + Compound Betamethasone) and control (normal saline placebo) injections will be identical in appearance (color and volume). Participants, surgeons, postoperative care providers, and outcome assessors will all be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 16, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)