Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07503691

Enrollment

180

Registered

2026-03-31

Start date

2026-04-01

Completion date

2029-12-31

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Greater Tuberosity Fracture, Rotator Cuff

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.

Interventions

PROCEDUREArthroscopic surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026