Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- The Disabilities of the Arm, Shoulder and Hand Score (DASH)
研究概览
简要总结
Humeral shaft fractures represent 1-3% of all fractures and 20% of the humeral fractures. These fractures have historically been treated mainly conservatively with good results. Recent development in fracture treatment and findings that certain fracture types are more prone to non-union and bracing-related functional problems of adjacent joints are somewhat common have caused increasing interest in treating these fractures surgically. Return to activities is also considered to be quicker among surgically treated patients.
The purpose of this study is to evaluate effectiveness and cost-effectiveness of surgical treatment of humeral shaft fractures. Patients with an unilateral humeral shaft fracture who are willing to participate in the study after informed consent are randomly assigned to two different treatment methods:
- Surgical treatment with an open reduction and internal fixation with a 4,5mm locking plate.
- Conservative treatment with functional bracing
The randomization is done using blocked randomization (block sizes are not known by the enrolling or assigning physician) and stratification is done according to fracture type (AO-OTA type A vs. type B/C) and radial nerve status (total/subtotal motor palsy vs. no palsy).
Standard follow-up visits at 6 weeks, 3, 6 and 12 months are arranged. Later follow-up visits are arranged at 2, 5 and 10 years for the study purpose. Patients fill evaluation forms and clinical and radiological assessments are made. The physiotherapist doing objective functional measurements is blinded to treatment method. Both study groups receive physiotherapy after the initial treatment.
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
- •Over 18 years old patient who agrees to the consent to participation in this study
- •Unilateral dislocated humeral shaft fracture (dislocation over thickness of the bone cortex, fracture below the level of insertion of pectoralis major muscle and 5 cm above the olecranon fossa)
- •Randomization can be done within 10 days and operation within 14 days after the initial trauma
- •Patient is willing to participate all follow-up visits
排除标准
- •Bilateral humeral shaft fracture
- •A significant concomitant trauma of the same upper extremity that warrants operative treatment (fracture, tendon injury, soft tissue trauma)
- •Other fracture or abdominal/thoracal trauma that warrants operative treatment
- •Open fracture
- •Pathological fracture
- •Multi-trauma patient
- •Vascular injury
- •Plexus injury
- •Previous trauma in the same upper extremity that causes functional deficit
- •Trauma or condition that warrants use of walking aid (crutches, wheelchair etc)
- •Disease that affects significantly general condition of the patient
- •Significantly impaired ability to co-operate for any reason (substance abuse, mental disorder, dementia)
- •Unwilling to accept both treatment methods
结局指标
主要结局
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
时间窗: at 12 months
次要结局
- Constant Score(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- Percentage of patients with acceptable symptom state (PASS)(at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years)
- Complications(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- Cost-effectiveness(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- Subjective assessment of the function of the elbow(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- Elbow ROM(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- Health-related quality of life (15D)(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
- The Disabilities of the Arm, Shoulder and Hand Score (DASH)(at 6 wks, 3, 6 mo, 2, 5, 10 years)
- Pain at rest and in activity, Numerical Rating Scale (NRS) 0-10(at 6 wks, 3, 6 mo, 12 mo, 2, 5, 10 years)
- Subjective assessment of the function of the upper extremity(6 wks, 3, 6, 12 mo, 2, 5, 10 years)
研究者
Lasse Rämö
MD, PhD
Töölö Hospital