A Randomized Prospective Multicenter Study Comparing Suture Button Suspensionplasty (SBS) with Ligament Reconstruction and Tendon Interposition (LRTI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Visual Analog Scale- Pain
研究概览
简要总结
A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.
详细描述
LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age fifty years or older
- •Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
- •Failure to respond to non-operative management
- •Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
- •Able to read and understand English or have interpreter available
排除标准
- •Previous surgery for CMC arthritis
- •Duration of symptoms for less than 6 months
- •Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
- •Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
- •Other significant ipsilateral wrist or hand pathology
- •A history of inflammatory arthropathy
- •A requirement for concomitant surgery for another condition
- •Any previous hand or wrist fracture
- •Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)
结局指标
主要结局
Visual Analog Scale- Pain
时间窗: 12 Months
Participants overall assessment of their pain at maximal key pinch loading on a 10 cm visual analogue scale
Disabilities of the Arm, Shoulder and Hand Questionnaire
时间窗: 12 Months
A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.
Patient Related Wrist Evaluation Questionnaire
时间窗: 12 Months
A 15 item questionnaire to measure wrist pain and disability pain in activities of daily living
次要结局
- Operative Time(Intraoperative)
- Range of Motion(12 Months)
- Strength(12 Months)
- Work Productivity and Activity Impairment: Specific Health Problem Questionnaire(12 Months)