Gait Analysis of Ankle Arthroplasty and Arthrodesis
Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedDecember 13, 2012
July 1, 2009
11.6 years
June 15, 2009
December 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Ankle Arthoplasty
ACTIVE COMPARATORPatients will undergo a Total Ankle Replacement procedure
Ankle fusion
ACTIVE COMPARATORPatients will undergo an Ankle Arthrodesis procedure
Interventions
A computerized motion analysis system to observe the effect of ankle arthroplasty versus ankle arthrodesis on the kinematic behaviour of the foot and ankle during gait.
Eligibility Criteria
You may qualify if:
- Symptomatic Ankle Arthritis
- Skeletal maturity
- Able to give informed consent
You may not qualify if:
- 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
- Pregnancy
- Workers compensation board patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Johnson & Johnsoncollaborator
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy R. Daniels, MD
Unity Health Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
June 1, 2002
Primary Completion
January 1, 2014
Last Updated
December 13, 2012
Record last verified: 2009-07