Pinch Grip and Functional Outcomes betweenHematoma Distraction Arthroplasty Versus Ligament Reconstruction Tendon Interposition Arthroplasty in Trapeziometacarpal Osteoarthritis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Functional results between HDA and LTRI using the QuickDASH test
研究概览
简要总结
To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.
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 (Participant)
盲法说明
Before each intervention, the type of procedure to perform was determined using a balanced simple randomization computer system to allocate treatments provided by the surgical area supervisor to the surgeon in the operation room.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who attended the hand unit's outpatient clinic at a regional trauma center with a diagnosis of grade III-IV TMC OA according to the Eaton-Littler radiological scale, who had previously failed conservative treatments (NSAIDs, splints, RHB, and corticosteroid injections) and desired surgical intervention with sufficient comprehension to participate in this study.
排除标准
- •Previous procedures on the same extremity distal to the elbow, central or peripheral neurological disease, and patient withdrawal.
结局指标
主要结局
Functional results between HDA and LTRI using the QuickDASH test
时间窗: From enrollment to end of follow-up at 1 year
Functional results were collected preoperatively and at 12 months postoperatively at the same facility, with a one-year follow-up. The score used to measure function and symptoms was the QuickDASH questionnaire. Patients responded to 11 statements, rating them from 1 to 5. Scores ranged from 0 (no disability) to 100 (most severe disability). Clinical evaluation and data collection were performed by a level 2 specialist, according to Tang et al.'s criteria of the Hand Unit.
Clinical results between HDA and LTRI with the quantification of grip and tip pinch strenght with JAMAR dynanometer.
时间窗: From enrollment to end of follow-up at 1 year
Grip and tip pinch strength were quantified using a BASELINE® hydraulic pinch gauge and dynamometer. Each patient completed three maximal pinch attempts, and the highest value was used for analysis.
次要结局
未报告次要终点
研究者
Anna Castellà Pujol
Resident of Orthopaedics and Traumatology
Hospital de la Santa creu i Sant Pau - Barcelona