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Gait Analysis of Ankle Arthroplasty and Arthrodesis

Primary Purpose

Ankle Arthritis

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Gait Analysis

About this trial

This is an interventional treatment trial for Ankle Arthritis

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Symptomatic Ankle Arthritis
Skeletal maturity
Able to give informed consent

Exclusion Criteria:

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

Sites / Locations

St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Ankle Arthoplasty

Ankle fusion

Arm Description

Patients will undergo a Total Ankle Replacement procedure

Patients will undergo an Ankle Arthrodesis procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00921076

First Posted

June 15, 2009

Last Updated

December 12, 2012

Sponsor

Unity Health Toronto

Collaborators

Johnson & Johnson

1. Study Identification

Unique Protocol Identification Number

NCT00921076

Brief Title

Gait Analysis of Ankle Arthroplasty and Arthrodesis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2002 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Johnson & Johnson

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ankle Arthoplasty

Arm Type

Active Comparator

Arm Description

Patients will undergo a Total Ankle Replacement procedure

Arm Title

Ankle fusion

Arm Type

Active Comparator

Arm Description

Patients will undergo an Ankle Arthrodesis procedure

Intervention Type

Behavioral

Intervention Name(s)

Gait Analysis

Intervention Description

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 Information:

Title

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Symptomatic Ankle Arthritis Skeletal maturity Able to give informed consent Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Timothy R. Danielst, MD

Phone

416-864-6060

Ext

5392

danielst@smh.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Ryan M. Khan, BA, CCRP

Phone

416-864-6060

Ext

3890

khanry@smh.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy R. Daniels, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timothy R. Daniels, MD

12. IPD Sharing Statement

Learn more about this trial

Gait Analysis of Ankle Arthroplasty and Arthrodesis

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