Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Contact Information
Primary
Hao Liang, MD
haoliang201@163.com
+86-13607008562
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 70
Treatments
Experimental: Combination Therapy Group
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone.
Active_comparator: Monotherapy (Control) Group
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Nanchang University

This content was sourced from clinicaltrials.gov