Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

ConditionsGreater Tuberosity Fracture Rotator Cuff

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorGuo Jialiang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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;

Disqualifiers

• 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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

180 Participants

are divided into 3 treatment groups

Group A: Conservative Treatment Group (CG)No intervention 0 interventions

Group B: Primary Surgery Group (PG)Experimental treatment 1 intervention

Group C: Delayed Surgery Group (DG)Experimental treatment 1 intervention

Trial outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guo Jialiang

Lead sponsor

Hebei Medical University Third Hospital

Sponsor institution

Source ClinicalTrials.gov

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