Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Pain control (visual analogical scale)
研究概览
简要总结
Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.
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 (Outcomes Assessor)
盲法说明
outcomes assessor will be blinded to the allocation of the patients
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy.
- •age between 65-85 a.
- •without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...)
- •acceptance to be part of the study.
排除标准
- •prosthetic surgery prior to the affected limb.
- •other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries).
- •no acceptance to participate in the study.
研究组 & 干预措施
group I (no immobilization)
patients will be allowed to freely use their arm without any immobilization after surgery
干预措施: shoulder immovilization sling (Device)
group II (3-week immobilization)
patients will be kept in an immobilization device for three weeks after surgery
干预措施: shoulder immovilization sling (Device)
结局指标
主要结局
Change in Pain control (visual analogical scale)
时间窗: determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively.
determination of pain control between groups at different time points with the aid of a visual analogical scale of 10 points, where 0 means no pain and 10 means maximum pain.
次要结局
未报告次要终点