Displaced Greater Tuberosity Fractures With Rotator Cuff Injury

N/ANot Yet RecruitingNCT07503691

Guo Jialiang180 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Greater Tuberosity Fracture Rotator Cuff

Interventions

Arthroscopic surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.