Advantages of Arthroscopic Rotator Cuff Repair With Transosseous Suture Technique. A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Arthroscopic transosseous fixation of rotator cuff tears has become an alternative to arthroscopic suture anchor.
This novel technique that allows surgeons to perform a standardized arthroscopic transosseous (anchor free) repair of rotator cuff tears can improve postoperative pain and reduce the incidence of shoulder stiffness.
The aim of the this study is to compare clinical outcomes of two groups of patients: patients that received an arthroscopic transosseous fixation using the ArthroTunneler tunneling device (Tornier Inc, Edina, Minnesota) versus patients that received an arthroscopic rotator cuff repair using suture anchors.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18, <65
- •Rotator cuff tears
- •Patients given written informed consent
排除标准
- •Age > 65, < 18
- •previous surgical intervention
- •Informed consent not accepted
- •Serious comorbidity
- •Metabolic Disorders
- •Active infections
- •Muscular Atrophy
- •Biceps Tenodesis
研究组 & 干预措施
Arthroscopic transosseous fixation
Patients with torn rotator cuff randomized to experimental treatment receive a complete arthroscopic transosseous cuff repair
干预措施: Arthroscopic transosseous fixation (Device)
Repair using suture anchors
Patients randomized to this arm receive an arthroscopic rotator cuff repair using suture anchors.
干预措施: Suture anchors (Device)
结局指标
主要结局
Pain
时间窗: first 28 days after surgery
Paracetamol/Codeine 500/30 is given to every patient at 08.00 and 20.00 for the first 5 days. The patient is highly recommended to indicate his pain at 19.30 and to write if there is any modification in the assumption of pain killers.
次要结局
- Shoulder Stiffness(Postoperative passive range of motion is measured 2 months after surgery)
研究者
Pietro Randelli, MD
Assistant Professor
University of Milan