Gait Analysis of Ankle Arthroplasty and Arthrodesis

Ankle Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921076
• Other study ID #: SMH 02-035
• Status: Recruiting
• Phase: Phase 4
• First received: June 15, 2009
• Last updated: December 12, 2012
• Start date: June 2002

Study information

• Verified date: July 2009
• Source: St. Michael's Hospital, Toronto
• Contact: Timothy R. Danielst, MD
• Phone: 416-864-6060
• Email: danielst[@]smh.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Arthritis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Johnson & Johnson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No