Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

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.

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Key information

Conditions

Greater Tuberosity Fracture Fractures, Bone Rotator Cuff Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Treatment and study plan

Arthroscopic surgery

Procedure

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

Other names: rehabilitation in CG group, arthroscopic sugery in PG and DG group

Primary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Guo Jialiang

Other

Registry information

Official study title

Three-Arm Randomized Controlled Trial Comparing Conservative Treatment, Primary Surgery, and Delayed Surgery for Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Mar 31, 2026
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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