A Prospective Randomized Controlled Trial of Open Arthrolysis Versus Non-surgical Treatment for Elbow Stiffness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Elbow range of motion improvement in degrees
研究概览
简要总结
This study compares patients with post traumatic elbow stiffness and evaluate the range of motion improvement with two types of treatment: surgical release versus non-surgical rehabilitation protocol with orthoses.
详细描述
The study of the treatment of post-traumatic stiffness of the elbow presents numerous challenges. Due to the great variability of the types of lesions, causes and symptomatology, there are great difficulties in the homogenization of protocols and in the comparison of results between the different treatments. Patients with different levels of severity and time of stiffness, presence of arthrosis or not, and significant symptoms such as pain.
For patients with elbow stiffness without vicious consolidation, pseudoarthrosis, intra-articular synthesis material or heterotopic ossification, and who have already failed conventional therapy, basically have two treatment options. Which will be the subject of this study: surgical release or non-surgical rehabilitation protocols with orthoses.
In meta-analysis, evaluating the elbow range of motion gain with rehabilitation protocols associated with orthoses, the mean gain varies from 20º to 40º, depending on the type of orthosis used. On the other hand a systematic review evaluated movement gain with different surgical techniques. Observed a mean gain of 51º for open releases, but with higher complication rates. However, there are no comparative studies in the literature comparing this 2 types of treatment for post traumatic elbow stiffness: surgical release and non-surgical rehabilitation protocol with orthoses in patients who have already performed conventional physiotherapy with no success.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous history of trauma that evolved with joint stiffness at the elbow
- •Range of movement of the elbow less than 100º or extension deficit greater than 30º or flexion less than 130º
- •More than six months from the initial trauma;
- •Skeletal maturity;
- •Have had previous physical therapy without the use of orthotics or continuous passive motion for at least 4 months;
- •Absence of the following findings:
- •Joint block, with range of motion equal to 0º;
- •Neurological limb injury;
- •Mental illness or inability to understand preoperative questionnaires;
- •Active infection;
- •Anterior infection at the elbow;
- •Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis, joint psoriasis, etc.).
- •Absence of the following radiographic changes:
- •Intra-articular synthesis material;
- •Presence of vicious consolidation of the distal articular surface of the humerus and proximal ulna;
- •Heterotopic ossification;
- •Pseudoarthrosis of previous elbow fracture;
- •Elbow incongruity;
- •Grade III and IV arthrosis
排除标准
- •Non-collaboration with rehabilitation program and postoperative follow-up;
- •Need to use external fixator after surgical release due to joint instability;
- •Death from non-intervention causes or loss of follow-up before the first functional evaluation (3 months).
结局指标
主要结局
Elbow range of motion improvement in degrees
时间窗: 6 months
The gain will be measured with a goniometer centered on the axis of rotation of the elbow by a external examiner.
次要结局
未报告次要终点
研究者
César Luiz Betoni Guglielmetti
Principal Investigator
University of Sao Paulo