Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Pain
研究概览
简要总结
Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty.
Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department
排除标准
- •known osteoporosis or other bone metabolism disorders
- •prior surgery on the toe scheduled for the intervention
- •immunodeficiency or immunosuppressive drug intake
- •pregnancy
- •non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery
- •anticoagulation therapy with the exception of acetylsalicylic acid
- •a lack of sufficient physical resilience to allow free self-mobilization and walking.
研究组 & 干预措施
Arthrodesis
Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire
干预措施: Arthrodesis (Procedure)
Resection arthroplasty
Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire
干预措施: Resection arthroplasty (Procedure)
结局指标
主要结局
Pain
时间窗: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Function
时间窗: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively
Change in function was evaluated using the American Orthopaedic Foot and Ankle Society score (ranging from 0 (severe impairment) to 100 (no problems with foot))
次要结局
- Osseous consolidation(6months postoperatively)
研究者
Dr. Ulf Krister Hofmann
Senior physician
University Hospital Tuebingen