跳至主要内容
临床试验/NCT05729542
NCT05729542招募中不适用

Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
Foot and Ankle Disability Index

研究概览

简要总结

This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.

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

入选标准

  • Ankle fracture with associated syndesmotic injury requiring surgery
  • Age 18 years or older
  • Ability to understand the content of the patient information/informed consent form

排除标准

  • Any not medically managed severe systemic disease
  • Patient preference for specific implant
  • Refusal of randomization
  • Pregnant patients
  • Prisoners
  • Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

研究组 & 干预措施

Arthrex Tightrope

Active Comparator

Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

干预措施: Arthrex Tightrope (Device)

Synthes Fibulink

Experimental

Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.

干预措施: Synthes Fibulink (Device)

结局指标

主要结局

Foot and Ankle Disability Index

时间窗: 1 year

Functional score with a 0-104 with higher scores indicating better function

Visual Analog Scale (VAS) Pain score

时间窗: 1 year

VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain

Olerud-Molander Ankle Score

时间窗: 1 year

Functional Score with a score of 0-100 with higher scores indicating better function

次要结局

  • Number of participants with medical or surgical complications(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Kent

Assistant Professor of Orthopaedic Surgery

University of California, San Diego

研究点 (1)

Loading locations...

相似试验