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Gait Analysis of Ankle Arthroplasty and Arthrodesis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921076
First Posted: June 16, 2009
Last Update Posted: December 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
  Purpose
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.

Condition Intervention Phase
Ankle Arthritis Behavioral: Gait Analysis Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.

Further study details as provided by St. Michael's Hospital, Toronto:

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 [ Time Frame: 12 months ]

Estimated Enrollment: 200
Study Start Date: June 2002
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ankle Arthoplasty
Patients will undergo a Total Ankle Replacement procedure
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.
Active Comparator: Ankle fusion
Patients will undergo an Ankle Arthrodesis procedure
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921076


Contacts
Contact: Timothy R. Danielst, MD 416-864-6060 ext 5392 danielst@smh.ca
Contact: Ryan M. Khan, BA, CCRP 416-864-6060 ext 3890 khanry@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Timothy R. Daniels, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Johnson & Johnson
Investigators
Principal Investigator: Timothy R. Daniels, MD St. Michael's Hospital, Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00921076     History of Changes
Other Study ID Numbers: SMH 02-035
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: December 13, 2012
Last Verified: July 2009