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临床试验/NCT03489876
NCT03489876撤回不适用

Comparison of Synthetic Cartilage Implant Versus Osteochondral Autologous Transfer for Advanced Hallux Rigidus, A Prospective Randomized Controlled Clinical Trial

University of Oklahoma0 个研究点开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Range of Motion

研究概览

简要总结

This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. This data will allow for accurate comparisons between the two groups in regards to functional outcome, clinical outcome, pain relief, and complications.

详细描述

First MTP joint arthritis or hallux rigidus is the most common arthritic condition of the foot. Historically, there have been several options to treat this condition surgically, but the current standard for advanced hallux rigidus is first MTP anthrodesis. Newer joint preserving procedures offer patients effective relief of pain and improving functional outcomes as well as maintaining, and potentially improving, range of motion for the first MTP joint. Osteochondral autograft transfer has been shown to be an effective treatment for hallux rigidus, and involves harvesting a small cylindrical osteochondral graft from a site remote of the first MTP joint and transferring the graft to the head of the first metatarsal. A new synthetic cartilage implant, Cartiva, has been shown to have equivalent functional outcomes, pain scores, and complications to anthrodesis, but the first MTP range of motion in the Cartiva group was maintained or even improved in some patients.

This is a prospective, randomized, controlled clinical trial comparing synthetic cartilage implantation versus osteochondral autograft transfer for treatment of first metatarsophalangeal (MTP) arthritis. The hypothesis is that clinical range of motion, pain scores, subjective clinical outcomes, and complications will not be clinically inferior with the synthetic cartilage implant group compared to the osteochondral autograft transfer group.

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
None

盲法说明

The computer-based randomization sequence will be concealed from investigators using REDCap.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 80 years old
  • Grade 2 or 3 hallux rigidus based on Coughlin and Shurnas classification
  • Presence of good bone stock as determined on pre-operative x-rays not requiring bone grafting
  • Capable of consenting for self

排除标准

  • Patients <18 years of age
  • Grade 1 or 4 hallux rigidus based on Coughlin and Shurnas classification
  • Active bacterial infection of the foot
  • Previous bilateral total knee arthroplasty
  • Previous fracture or significant trauma to the ipsilateral knee
  • Inflammatory anthropathy
  • Inadequate bone stock
  • Previous anthrodesis or arthroplasty performed on the ipsilateral first MTP

结局指标

主要结局

Range of Motion

时间窗: 2 years

Pre-operative and post-operative clinical range of motion of the first MTP joint

Patient's Pain Level

时间窗: 2 years

Pre-operative and post-operative visual analog pain scale

次要结局

  • Clinically-Assessed Foot and Ankle Function(2 years)
  • Patient's Quality of Life(2 years)
  • Secondary Surgical Intervention(2 years)
  • Health Status(2 years)
  • Surgical Complications(2 years)
  • Implant Failure(2 years)

研究者

申办方类型
Other
责任方
Sponsor

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