Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

March 25, 2026 updated by: Guo Jialiang

Three-Arm Randomized Controlled Trial Comparing Conservative Treatment, Primary Surgery, and Delayed Surgery for 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative Treatment Group (CG)
no operation
Experimental: Primary Surgery Group (PG)
operation immediately
Procedure: Arthroscopic surgery
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
Experimental: Delayed Surgery Group (DG)
operation after 3 months
Procedure: Arthroscopic surgery
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guo Jialiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GJL003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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