BASTION - BASe of Thumb Osteoarthritis Management Non-inferiority Trial: Surgical Treatment of First Carpometacarpal Joint Osteoarthritis: A Comparison Between Joint Replacement and Trapeziectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Hand grip strength
研究概览
简要总结
The goal of this clinical trial is to learn if the surgical method with total joint arthroplasty, (TOUCH joint prosthesis), is as good as or better than the traditional surgical method, trapezectomy, to treat thumb base joint osteoarthritis.
The main questions it aims to answer are:
Does surgery with total joint arthroplasty provide better power grip and pinch grip strength compared to traditional surgery?
What is the long-term risk of complications for both methods?
Which method is more cost-effective for the healthcare system?
Researchers will compare total joint arthroplasty (TOUCH) to trapezectomy (a procedure where a bone in the thumb base is removed) to see which method provides the best results for the patient.
Participants will:
Be randomized to undergo either an operation with total joint arthroplasty or a trapezectomy.
Undergo an initial evaluation and a health economic cost analysis after one year.
Attend follow-up checkups at 2, 5, and 10 years post-surgery to evaluate long-term function and the durability of the prosthesis.
详细描述
Background and Rationale:
Basal joint arthritis of the thumb (trapeziometacarpal osteoarthritis) is a common condition causing pain and reduced hand function. While trapeziectomy with ligament reconstruction/capsuloplasty has long been a gold standard, total joint arthroplasty, such as the TOUCH prosthesis, has gained popularity. However, there is a lack of high-quality prospective randomized controlled trials (RCTs) comparing these methods regarding long-term functional outcomes, complication rates, and cost-effectiveness. This study aims to compare the clinical and health-economic outcomes of total joint arthroplasty with TOUCH prosthesis versus trapeziectomy with capsuloplasty.
Study Design and Randomization:
This is a prospective, randomized controlled trial. Following informed consent obtained by the attending surgeon, participants are randomized to either:
- Total joint arthroplasty using the TOUCH prosthesis.
- Trapeziectomy with capsuloplasty. Randomization is performed in close proximity to the day of surgery. Due to the nature of the interventions, participants are informed of the surgical method postoperatively.
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
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years at inclusion
- •CMC-joint osteoarthritis grade 1-3 (Eaton-Littler classification)
- •Rest pain or pain reducing hand function with indication for surgery
- •Insufficient relief from non-operative treatment for ≥3 months (orthosis, OTC analgesics, cortisone injection)
- •Eligible for both prosthesis and trapezectomy per including surgeon
- •Non-smoker or complete smoking cessation ≥6 weeks prior to surgery
排除标准
- •Previous surgery to thumb base or STT-joint
- •Ongoing chronic pain condition
- •Dementia or cognitive impairment
- •Trapezium height <7 mm on plain radiograph
- •Active smoker
- •Osteoarthritis grade 4 (Eaton-Littler)
研究组 & 干预措施
Arm 1 -Dual Mobility Prosthesis (TOUCH)
TOUCH Total Joint Arthroplasty (n=42). Implantation of TOUCH trapeziometacarpal prosthesis (Kerimedical). Soft bandage for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
干预措施: Implantation of trapeziometacarpal prosthesis (Device)
Arm 2 - Trapeziectomy and Capsular Reconstruction
Trapezectomy with capsuloplasty (n=42). Excision of trapezium with dorsal capsule flap capsuloplasty. Cast immobilization for 3 weeks postoperatively, followed by rehabilitation per national guidelines.
干预措施: Trapeziectomy with Capsuloplasty (Procedure)
结局指标
主要结局
Hand grip strength
时间窗: Measured at 12 months postoperatively
Hand grip strength (JAMAR dynamometer) at 12 months post operatively
次要结局
- Duration of sick leave(Measured at 12 months postoperatively)
- Key-pinch grip strength(Measured at 6 weeks, 12 weeks, and 12 months postoperatively)
- Pinch grip strength(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Postoperative Pain Intensity on a Numeric Rating Scale (NRS)(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Range of movement(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Metacarpophalangeal (MCP)-joint hyperextension(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Complications(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Use of analgesics(Measured at 12 months postoperatively)
- Patient-reported outcomes EQ-5D(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Patient-reported outcomes QUICK-DASH(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Patient-reported outcomes PRWHE(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Patient-reported outcomes Michigan hand questionnaire (MHQ)(Measured at 6 weeks, 12 weeks and 12 months postoperatively)
- Patient-reported outcomes Michigan hand questionnaire HQ-8(Measured at 6 weeks, 12 weeks and 12 months postoperatively)