Gait Analysis of Ankle Arthroplasty and Arthrodesis

Unity Health Toronto

Status and phase: Unknown; Phase 4

Conditions: Ankle Arthritis

Treatments: Behavioral: Gait Analysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00921076

SMH 02-035

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Ankle Arthoplasty

Active Comparator group

Description:

Patients will undergo a Total Ankle Replacement procedure

Treatment:

Behavioral: Gait Analysis

Ankle fusion

Active Comparator group

Description:

Patients will undergo an Ankle Arthrodesis procedure

Treatment:

Behavioral: Gait Analysis