Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evaluation and assessment of DASH scores.
研究概览
简要总结
This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.
详细描述
This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.
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)
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 treated at Orlando Regional Medical Center,
- •18 years or older,
- •Have an acute (less than 4 week old) injury with instability of the DRUJ.
排除标准
- •Younger than 18 years old,
- •Patients with an injury over 4 weeks old,
- •Previous history of ipsilateral upper extremity trauma,
- •Functional deficit,
- •Those who are unable to complete postoperative assessments. -
研究组 & 干预措施
Serial Casting
Participants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention.
干预措施: Serial casting/splinting (Procedure)
Kirschner wires
Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically.
干预措施: Percutaneous fixation (Procedure)
Foveal repair
Participants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention.
干预措施: Foveal repair (Procedure)
结局指标
主要结局
Evaluation and assessment of DASH scores.
时间窗: Up to 5 years.
To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score.
次要结局
- Visual Analog Pain scale(Up to 5 years.)
研究者
Brett Lewellyn
Orthopedic surgeon, Hand specialist
Orlando Health, Inc.
