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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

NCT ID: NCT07311616

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Supraspinatus Tear

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Prophylactic extensive shoulder release and capsular release

Intervention Type 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.

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair surgery

Control Group

The control group only received arthroscopic rotator cuff repair surgery.

Group Type OTHER

Arthroscopic rotator cuff repair

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair surgery

Interventions

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Prophylactic extensive shoulder release and capsular release

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.

Intervention Type PROCEDURE

Arthroscopic rotator cuff repair

Arthroscopic rotator cuff repair surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Medium to small-sized (tear size \<3 cm) full-thickness supraspinatus muscle tears
2. 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
3. About to undergo ARCR
4. No history of trauma
5. Patient consent to participate

Exclusion Criteria

1. There was a history of previous surgery on the ipsilateral shoulder
2. Other injuries or lesions of the ipsilateral shoulder (such as glenohumeral arthritis, combined acromioclavicular joint dislocation, brachial plexus injury, etc.)
3. It can not be completely repaired or even repaired during operation
4. Have uncontrolled epilepsy or psychological illness
5. Patients who were assessed as not suitable for inclusion in the study group
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yiming Zhu

Role: CONTACT

Phone: 86-13693245245

Email: [email protected]

Facility Contacts

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Yiming Zhu

Role: primary

Other Identifiers

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MR-11-25-079098

Identifier Type: -

Identifier Source: org_study_id