Three-Arm Randomized Controlled Trial Comparing Conservative Treatment, Primary Surgery, and Delayed Surgery for Displaced Greater Tuberosity Fractures With Rotator Cuff Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
结局指标
主要结局
SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms.
时间窗: Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months
次要结局
未报告次要终点
研究者
Guo Jialiang
Clinical Professor
Hebei Medical University Third Hospital