跳至主要内容
临床试验/NCT01048450
NCT01048450已完成不适用

A Multi-Center Retrospective Review of Resectional Arthroplasty, Arthrodesis and, Hemi-Metallic Joint Implants in the Surgical Treatment of End Stage Hallux Rigidus

American College of Foot and Ankle Surgeons12 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
158
试验地点
12
主要终点
Subjective: pain, function, alignment

研究概览

简要总结

The purpose of this study is to examine the long-term outcomes for the surgical treatment of end stage degeneration in the big toe joint.

详细描述

Hallux rigidus is a degenerative process that occurs in the first metatarsophalangeal joint (MTPJ). There are a variety of surgical treatment options available for its treatment including joint sparing and joint destructive procedures. Patients with end stage arthritis are often given several surgical options for the treatment of the first MTPJ. The procedures are correlated to the patient's age, type of shoe gear, activity level, Body Mass Index, degree of arthritis, desire for joint mobility and bone density. This proposal outlines a retrospective study on the long-term efficacy of joint resection, joint fusion, and hemi-metallic first MTPJ implants. A multi-center study of 300 subjects who received surgical repair for end stage arthritis of the first MTPJ will be evaluated. Subjective assessment for pain, function and alignment as well as objective radiographic evaluation will be performed. Further, the frequency and types of adverse events associated with the three surgical techniques will be assessed. The results of this study will provide valuable information to foot and ankle surgeons in making appropriate decisions regarding the treatment options for end stage hallux rigidus.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End stage hallux limitus/rigidus
  • Status post 1 year since having the surgery
  • Must have had a joint resection, fusion, or hemi-metallic implant

排除标准

  • History of seropositive or seronegative arthritis
  • Have had a primary surgery before then had one of the above surgeries performed

结局指标

主要结局

Subjective: pain, function, alignment

时间窗: At least 1 year after surgical intervention

次要结局

  • Frequency and types of undesired effects(At least 1 year after surgical intervention)
  • Demographic data and trends(At least 1 year after surgical intervention)

研究者

申办方类型
Other

研究点 (12)

Loading locations...

相似试验

Surgical Treatment for Hallux Rigidus | 临床试验