Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT00921076

Conditions

Ankle Arthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Gait Analysis

Study Details

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.

Conditions

Ankle Arthritis

Study ID

NCT00921076

Start date

Jun, 2002

Status verified date

Jul, 2009

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ankle Arthoplasty

Patients will undergo a Total Ankle Replacement procedure

active comparator: Ankle fusion

Patients will undergo an Ankle Arthrodesis procedure

Interventions

Gait 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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Timothy R. Danielst, MD

416-864-6060danielst@smh.ca

Ryan M. Khan, BA, CCRP

416-864-6060khanry@smh.ca

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator:

Timothy R. Daniels, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Dec 13, 2012

Last verified

Jul, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2012-12-13.