MUlticenter Randomized Controlled Trial on Nonoperative Versus Operative Treatment for Acute Complete tearS of the Ulnar Collateral ligAment of the Thumb: Cost- Effectiveness and Functional Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Michigan Hand outcome Questionnaire (MHQ)
研究概览
简要总结
A complete rupture of the ulnar collateral ligament (UCL) of the thumb must heal in order to regain proper function of the thumb. Guidelines recommend surgery for complete UCL ruptures, including Stener lesions. This recommendation is based on expert opinion, anatomic theories and low quality retrospective case series. High quality studies comparing cast immobilization with operative treatment are lacking. Research has shown that in about 9 out of 10 patients, a complete UCL rupture, including Stener Lesions, can also be treated with a cast alone for 6 weeks and no surgery is needed. We hypothesize that cast immobilization is non-inferior regarding functional outcome and carries concomitant lower costs compared with operative treatment for complete UCL ruptures, including Stener Lesions.
The project aims to conduct a multicenter randomized controlled trial and cost-effectiveness analysis comparing operative and nonoperative treatment for complete UCL ruptures, including Stener Lesions. The project will take four years, from preparation to reporting of the results. In the following years, implementation will be achieved in collaboration with the Dutch hand surgery committees (NVvH and NVPC), health insurance companies, and medical experts.
Research question Is nonoperative treatment with splint immobilization non-inferior to immediate operative treatment regarding functional outcome and does it lead to lower costs in adult patients with an acute complete UCL rupture, including Stener Lesions?
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
- None
盲法说明
Not possible for surgical intervention vs cast immobilization
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
- •Patients 18 years and older
- •Dutch or English speaking patients
- •Patients with an acute complete UCL rupture, with or without a Stener Lesion, diagnosed using physical examination, performed by the hand surgeon. When providing radically directed force to the proximal phalanx (radial deviation stress) as the thumb metacarpal is stabilized, criteria 1 AND 2 must be present to confirm the diagnosis of a complete UCL rupture:
- •no firm endpoint in the MCP joint AND
- •at least more than 35 degrees of laxity in the MCP joint (measured with the MCP joint in extension or in 30 degrees of flexion) OR more than 15 degrees difference in laxity compared with the uninjured side.
排除标准
- 未提供
研究组 & 干预措施
Cast immobilization
Cast immobilization to immobilize the thumb for 4 weeks. After 2 weeks the thumb will be re-examined to determine if surgery is required. It is expected that at re-evaluation at 2 weeks after starting the cast treatment about 1 in 10 patients will still need surgery.
干预措施: Cast immobilization (Procedure)
Surgery
The intervention is compared to surgery, which is standard treatment for complete ulnar collateral ligament ruptures.
干预措施: Surgical treatment (Procedure)
结局指标
主要结局
Michigan Hand outcome Questionnaire (MHQ)
时间窗: 6 months
The MHQ, expressed as the MHQ at 6 months (from randomization to 6 months after) is the primary endpoint of the study. The MHQ is a validated tool for assessment of functional outcome in patients with pathology of the hand. The MHQ is a questionnaire divided in six subscales; overall hand function, activities of daily living (ADLs), pain, work performance, aesthetics and patient satisfaction with hand function. Each subscale has a formula to calculate a score. The final score is a summation of the six individual item-scores divided by six and goes from 0 (severe disability) to 100 (no disability).
次要结局
- Patient-Specific Functional Scale (PSFS)(at randomization, 2, 3, 6 and 12 months after randomization.)
- EQ-5D-5L(at randomization, 2, 3, 6 and 12 months after randomization.)
- Michigan Hand outcome Questionnaire (MHQ)(at randomization, 2, 3 and 12 months after randomization.)
- The Numeric Pain Rating Scale (NPRS)(at randomization, 2, 3, 6 and 12 months after randomization.)
- Patient satisfaction(at randomization, 2, 3, 6 and 12 months after randomization.)
- The adapted Dutch institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ)(at 2 months (over the last 2 months), 3 (over the last month), 6 (over the last 3 months), and 12 (over the last 3 months) months after randomization)
- Range of motion (ROM)(4 weeks, 3, 6 and 12 months after randomization.)
- Kapandji-score(4 weeks, 3, 6 and 12 months after randomization.)
- Complications(4 weeks, 3, 6 and 12 months after randomization.)
- The adapted Dutch institute for Medical Technology Assessment (iMTA)Productivity Cost Questionnaire (iPCQ)(at 2 months (over the last 2 months), 3 (over the last month), 6 (over the last 3 months), and 12 (over the last 3 months) months after randomization)
- Grip strength(4 weeks, 3, 6 and 12 months after randomization.)
- Pinch strength(4 weeks, 3, 6 and 12 months after randomization.)