Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

NCT07503691 | Not Yet Recruiting

• 1 other identifier: GJL003
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Type: Prospective, three-arm parallel randomized controlled trial (RCT) Study Objective: To compare the 12-month/5 years/10years functional outcomes, morphological healing, cost-effectiveness, and complication rates of three treatment strategies for displaced greater tuberosity (GT) fractures with rotator cuff injury, and to optimize the individualized treatment strategy for GT fractures. Study Setting: multicenter clinical trial, conducted in the Department of Orthopedics. Study Period: April 2026 -April 2036.

Conditions

Greater Tuberosity Fracture; Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms.

  Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months

Study Arms (3)

Conservative Treatment Group (CG)

NO INTERVENTION

no operation

Primary Surgery Group (PG)

EXPERIMENTAL

operation immediately

Procedure: Arthroscopic surgery

Delayed Surgery Group (DG)

EXPERIMENTAL

operation after 3 months

Procedure: Arthroscopic surgery

Interventions

Arthroscopic surgery PROCEDURE

Conservative Treatment Group (CG): rehabilitation only ; Primary Surgery Group (PG): surgery early; Delayed Surgery Group (DG): surgery late

Also known as: rehabilitation in CG group, arthroscopic sugery in PG and DG group

Delayed Surgery Group (DG); Primary Surgery Group (PG)

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 18-76 years, male or female;
• Diagnosed with displaced GT fracture (displacement distance ≥1mm) combined with rotator cuff injury (partial tear or full-thickness tear) by computed tomography (CT) or magnetic resonance imaging (MRI);
• Time from fracture to admission ≤72 hours (acute phase);
• No severe heart, liver, kidney or other underlying diseases, and able to cooperate with 12-month complete follow-up;
• Signed informed consent and voluntarily participated in the trial.

You may not qualify if:

• Pathological fracture or old fracture (\>3 weeks);
• Complicated with shoulder dislocation or other proximal humeral fractures;
• Previous shoulder surgery history, rheumatoid arthritis, or severe osteoporosis;
• Mental illness, cognitive impairment, unable to complete functional scoring;
• Poor follow-up compliance, expected to be unable to complete 12-month follow-up.

Sponsors & Collaborators

• Guo Jialiang: lead

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Arthroscopy; Rehabilitation

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share