Gait Analysis of Ankle Arthroplasty and Arthrodesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by St. Michael's Hospital, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00921076
First received: June 15, 2009
Last updated: December 12, 2012
Last verified: July 2009

June 15, 2009
December 12, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00921076 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
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
Both
40 Years to 85 Years
No
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
Canada
 
NCT00921076
SMH 02-035
No
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