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Not yet recruiting NCT07503691

Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

No phase Interventional Greater Tuberosity Fracture Rotator Cuff

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arthroscopic surgery.
Who it may be relevant to
Registry conditions: Greater Tuberosity Fracture, Rotator Cuff. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07503691 · GJL003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗