Gait Analysis of Ankle Arthroplasty and Arthrodesis

Phase 4

• Conditions: Ankle Arthritis
• Interventions: Behavioral: Gait Analysis

• Registration Number: NCT00921076
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Status Verified: 2009-07
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Symptomatic Ankle Arthritis
2. Skeletal maturity
3. Able to give informed consent

Exclusion Criteria

1. Avascular Necrosis of Talus
2. Obesity (BMI >30)
3. Prior Ankle fusion or arthroplasty
4. Active or prior infection within 12 months
5. Medical condition precluding major surgery
6. Severe ipsilateral mid or hind foot deformity
7. Severe osteoporotic or osteopenic bone
8. Neuromuscular impairment
9. Age less than 40 years old
10. Cognitive or psychiatric impairment prohibiting accurate follow-up
11. Pregnancy
12. Workers compensation board patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle Arthoplasty	Gait Analysis	Patients will undergo a Total Ankle Replacement procedure
Ankle fusion	Gait Analysis	Patients will undergo an Ankle Arthrodesis procedure

Primary Outcome Measures

Name	Time	Method
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	12 months

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada