A Study on the Effectiveness of Preventive Extensive Release of the Rotator Interval and Joint Capsule to Reduce Postoperative Stiffness in Arthroscopic Rotator Cuff Repair

NCT07311616 | Not Yet Recruiting

• 1 other identifier: MR-11-25-079098
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of rotator cuff injuries is high, especially among the elderly. With the aging of the population, the number of surgical patients has increased significantly. However, in the early stage after arthroscopic rotator cuff repair, a considerable proportion of patients are troubled by shoulder joint stiffness, which greatly affects the quality of life and satisfaction of patients after the operation. Despite this, there is still a lack of clear evidence-based medical evidence regarding whether preventive extensive shoulder release and joint capsule release during arthroscopic rotator cuff repair can effectively prevent or alleviate postoperative shoulder stiffness. To clarify this clinical issue, this project intends to conduct a single-blind randomized controlled trial (RCT). Before the operation, patients will be randomly divided into two groups under blinding conditions: the experimental group will receive arthroscopic rotator cuff repair surgery along with preventive extensive shoulder joint release and joint capsule release, while the control group will only receive arthroscopic rotator cuff repair surgery. After the operation, the investigators will conduct follow-up visits for 3 months, 6 months and 12 months for the two groups of patients, and perform magnetic resonance imaging (MRI) at the 12th month to assess the healing of the rotator cuff tendons. ASES score, Constant-Murley score, Visual Analogue Scale (VAS) pain score and active range (ROM) assessment were conducted before the operation and at the follow-up at 3 months, 6 months and 12 months after the operation. The occurrence of postoperative complications of the patients was counted at the last follow-up. Through this study, the investigators expect to provide scientific and effective guidance for the prevention of postoperative adhesions of the shoulder joint.

Conditions

Supraspinatus Tear

Keywords

Rotator cuff repair; Postoperative stiffness; Joint capsule release; Randomized controlled trial; Range of motion of the shoulder joint

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain and Daily Functional Evaluation Measured By American Shoulder and Elbow Surgeons Score (ASES Questionnaire)

  This outcome measure will be assessed using the American Shoulder and Elbow Surgeons Score (ASES), a disease-specific patient-reported outcome questionnaire. The scale consists of two key dimensions: pain (50 points, measured by Visual Analog Scale) and daily living functions (50 points, evaluating 10 activities including dressing, combing hair, and using the toilet). The total score ranges from 0 to 100, with higher scores indicating better shoulder function and less pain.

  At baseline and at 3, 6 and 12 months after the operation.

Secondary Outcomes (4)

• Shoulder Function Measured By Constant-Murley Score

  At baseline and at 3, 6 and 12 months after the operation.

• Patient-Reported Shoulder Pain Intensity Measured by Visual Analogue Scale (0-10 Scale)

  At Basline, 1 day after the operation, and 3, 6, and 12 months after the operation

• Range of Motion (ROM)

  At baseline and at 3, 6, and 12 months after operation

• Rate of Postoperative Complications

  At 6 weeks, 3 months, 6 months and 12 months after the operation.

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group underwent arthroscopic rotator cuff repair combined with preventive extensive shoulder release and capsular release simultaneously.

Procedure: Prophylactic extensive shoulder release and capsular release; Procedure: Arthroscopic rotator cuff repair

Control Group

OTHER

The control group only received arthroscopic rotator cuff repair surgery.

Procedure: Arthroscopic rotator cuff repair

Interventions

Arthroscopic rotator cuff repair PROCEDURE

Arthroscopic rotator cuff repair surgery

Control Group; Experimental Group

Prophylactic extensive shoulder release and capsular release PROCEDURE

Before rotator cuff repair, extensive release of the rotator cuff space is performed first, as well as comprehensive release of the middle glenohumeral ligament, inferior glenohumeral ligament, coracohumeral ligament, the area around the subscapularis tendon, the subacromial capsule, and the anterior and posterior inferior joint capsules.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medium to small-sized (tear size \<3 cm) full-thickness supraspinatus muscle tears
• There was no shoulder joint stiffness before the operation. The range of motion of the joint was at least 160° for passive forward flexion under ROM anesthesia, 60° for external rotation when abduction was 0°, and equal to or greater than 60° for passive internal rotation at the level of the 10th thoracic vertebra
• About to undergo ARCR
• No history of trauma
• Patient consent to participate

You may not qualify if:

• There was a history of previous surgery on the ipsilateral shoulder
• Other injuries or lesions of the ipsilateral shoulder (such as glenohumeral arthritis, combined acromioclavicular joint dislocation, brachial plexus injury, etc.)
• It can not be completely repaired or even repaired during operation
• Have uncontrolled epilepsy or psychological illness

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Joint Capsule Release

Intervention Hierarchy (Ancestors)

Arthroscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Central Study Contacts

Yiming Zhu

CONTACT

86-13693245245; zhu_yiming@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 31, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available beginning 6 months after the publication of the primary study results and will remain accessible for at least 3 years.

Locations

CN (1)