A Clinical Research on Repair of Massive-large Rotator Cuff Tears

NCT05214651 | Recruiting

• 1 other identifier: M2021389
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed as a randomized controlled trial, a total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group. The functional outcome was measured at the preoperatively, 3, 6, 12 and 24 months postoperatively, using the visual analog scale (VAS) for pain, active and passive ROM, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). The anatomic outcome was evaluated using magnetic resonance imaging at 3, 6, 12 and 24 months postoperatively. The clinical results were compared between the novel double row technique group and suture bridge double row technique group.

Conditions

Rotator Cuff Tears

Keywords

novel double row technique; suture bridge double row technique; massive-large rotator cuff tears; retear rate

Outcome Measures

Primary Outcomes (1)

• The retear rate of large to massive rotator cuff tears

  This study statistically compared the retear rate of large to massive rotator cuff tears treated with suture bridge double row technique with that treated with novel double row technique.

  The incidence of retear during 24 months postoperatively

Secondary Outcomes (1)

• functional scores of the shoulder

  functional scores of the shoulder were assessed at following time points: preoperatively; 3, 6, 12 and 24 months postoperatively

Study Arms (2)

novel double row group

EXPERIMENTAL

This is the experimental group, and 26 participants will be enrolled, a novel double row technique will be using to repair the large - massive rotator cuff tears in in this group.

Procedure: novel double row

suture bridge double row group

ACTIVE COMPARATOR

This is the control group, and 26 participants will be enrolled, a suture bridge double row technique will be using to repair the large - massive rotator cuff tears in in this group in routine.

Procedure: suture bridge double row

Interventions

novel double row PROCEDURE

The large - massive rotator cuff tears in in this group will be treated using a novel double row repairing techniques.

novel double row group

suture bridge double row PROCEDURE

The large - massive rotator cuff tears in in this group will be treated using a suture bridge double row repairing techniques.

suture bridge double row group

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• preoperative magnetic resonance imaging (MRI) diagnosis of a large - massive sized rotator cuff tear (\>3cm), which was confirmed during operation
• chronic tear
• older than 17 years and younger than 75 years
• without surgical contraindications and willing to participate

You may not qualify if:

• poor quality rotator cuff and irreparable tear
• severe glenohumeral arthritis
• previous shoulder surgery
• accompanied by dislocation or fracture of shoulder
• refusal to participate

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ping Liu, M.D.

  Institute of Sports Medicine, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Liu, M.D.

CONTACT

01082267020; bjusmlp@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 31, 2022
• Study Start: June 8, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)