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Clinical Trials/NCT00921076
NCT00921076
Unknown
Phase 4

Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.

Unity Health Toronto1 site in 1 country200 target enrollmentJune 2002
ConditionsAnkle Arthritis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Ankle Arthritis
Sponsor
Unity Health Toronto
Enrollment
200
Locations
1
Primary Endpoint
The primary outcome measure will be micro motion, consisting of component migration and rotation relative to the talus and distal tibia. This will be measured utilizing RSA with bi-planar stereo X-rays taken at several intervals: before weight bearing is
Last Updated
13 years ago

Overview

Brief Summary

Surgical options for managing hindfoot arthritis include: joint fusion, total ankle joint replacement or osteotomies (realignment) of bones. Fusion of arthritic hindfoot joints has been the accepted method of managing hindfoot arthritis for over a century. Recently, total ankle replacement has evolved as a treatment option for patients with end stage ankle arthritis. A comparison of gait for patients before and after hindfoot fusion or total ankle replacement will give further information about the outcome of this treatment. The principal aim of this project is to assess the effect of total ankle replacement or hindfoot fusion on gait. We are also interested in the outcome of the surgery and its effect on your symptoms (eg. pain and mobility). The results of this study will aid researchers in assessing this new treatment modality. Your involvement in this study is critical for the researchers to further analyze this new form of treatment and your time and involvement is appreciated.

Registry
clinicaltrials.gov
Start Date
June 2002
End Date
January 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Symptomatic Ankle Arthritis
  • Skeletal maturity
  • Able to give informed consent

Exclusion Criteria

  • Avascular Necrosis of Talus
  • Obesity (BMI \>30)
  • Prior Ankle fusion or arthroplasty
  • Active or prior infection within 12 months
  • Medical condition precluding major surgery
  • Severe ipsilateral mid or hind foot deformity
  • Severe osteoporotic or osteopenic bone
  • Neuromuscular impairment
  • Age less than 40 years old
  • Cognitive or psychiatric impairment prohibiting accurate follow-up

Outcomes

Primary Outcomes

The primary outcome measure will be micro motion, consisting of component migration and rotation relative to the talus and distal tibia. This will be measured utilizing RSA with bi-planar stereo X-rays taken at several intervals: before weight bearing is

Time Frame: 12 months

Study Sites (1)

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