Gait Analysis of Ankle Arthroplasty and Arthrodesis

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. Identifier: NCT00921076
Recruitment Status : Unknown
Verified July 2009 by St. Michael's Hospital, Toronto.
Recruitment status was:  Recruiting
First Posted : June 16, 2009
Last Update Posted : December 13, 2012
Johnson & Johnson
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

June 15, 2009
June 16, 2009
December 13, 2012
June 2002
January 2014   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00921076 on Archive Site
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Gait Analysis of Ankle Arthroplasty and Arthrodesis
Gait Analysis of Patients Undergoing Total Ankle Arthroplasty, Ankle Arthrodesis, Tibiotalocalcaneal or Pantalar Fusion.
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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ankle Arthritis
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 Arthoplasty
    Patients will undergo a Total Ankle Replacement procedure
    Intervention: Behavioral: Gait Analysis
  • Active Comparator: Ankle fusion
    Patients will undergo an Ankle Arthrodesis procedure
    Intervention: Behavioral: Gait Analysis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
SMH 02-035
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St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Johnson & Johnson
Principal Investigator: Timothy R. Daniels, MD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP