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Gait Analysis of Ankle Arthroplasty and Arthrodesis

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00921076
Enrollment
200
Registered
2009-06-16
Start date
2002-06-30
Completion date
Unknown
Last updated
2012-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Arthritis

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.

Interventions

BEHAVIORALGait Analysis

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.

Sponsors

Johnson & Johnson
CollaboratorINDUSTRY
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 is12 months

Countries

Canada

Contacts

Primary ContactTimothy R. Danielst, MD
danielst@smh.ca416-864-6060
Backup ContactRyan M. Khan, BA, CCRP
khanry@smh.ca416-864-6060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026