Dynamic Imaging of the Hip for Pre-operative Planning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. P. Beaule, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00605969
First received: January 21, 2008
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

One of the leading causes of hip arthritis is femoro-acetabular impingement which means the hip joint is deformed such that the hip joint jams in the front when the hip is bent all the way forward. This can lead to significant damage to the hip joint and may result in the need for a total hip replacement. However, if detected early, this deformity can be treated surgically by reshaping the hip joint. If the hip joint could be better visualized before surgery, then surgeons would be able to develop less invasive surgical techniques to correct this deformity.

In this study, we are trying to develop a way to help surgeons visualize the hip joint before surgery in order to assist with pre-operative planning. This will be done by comparing the dynamic hip images in patients with femoro-acetabular impingement to the hip images of healthy volunteers with no hip problems.


Condition Intervention
Femoroacetabular, Impingement
Procedure: Motion analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Hip Reconstruction and Modeling for Surgical Pre-Operative Planning

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Motion analysis [ Time Frame: Pre-op ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: May 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FAI patients Procedure: Motion analysis
Motion analysis and CT
Placebo Comparator: Control Procedure: Motion analysis
Motion analysis and CT

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All participants (patients and controls) must be between the ages of 18 and 55, with a BMI less than 35.

The patients must have a probable diagnosis of femoro-acetabular impingement (FAI). Their hip pain must have been ongoing for at least 3 months. The controls must have a normal hip as defined by AP pelvis radiographs.

Exclusion Criteria:

  • Participants (patients and controls) will be excluded if they are pregnant, have a knee injury or replacement, or history of childhood hip disease. Patients will be excluded if have they have arthritis, previous fracture or trauma to the hip, previous hip surgery, dysplasia, or avascular necrosis. Controls will be excluded if they have hip pain.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605969

Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Paul E Beaule, MD, FRCSC University of Ottawa / The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Dr. P. Beaule, MD, FRCSC, Head, Adult Reconstruction, The Ottawa Hospital., Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00605969     History of Changes
Other Study ID Numbers: 2006-552
Study First Received: January 21, 2008
Last Updated: January 14, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
femoroacetabular, impingement

ClinicalTrials.gov processed this record on August 21, 2014