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Completed

NCT Number: NCT00605969

Dynamic Imaging of the Hip for Pre-operative Planning

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

About this study

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 femoroacetabular impingement to the hip images of healthy volunteers with no hip problems.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motion analysis

Procedure

Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.

Computed Tomography

Diagnostic Test

Participants will undergo computed tomography (CT) scan of their hip.

Primary outcomes

  1. Validation of kinematic model of hip joint

    Time frame: Within 6 months of recruitment

    Development of a kinematical model of the hip joint to simulate virtual joint motion. This will be done by using automatic segmentation using the CT data to generate models.

Secondary outcomes

  1. Joint Kinetics

    Time frame: 24 months

    Retro-reflective markers will be placed on each participant in a laboratory setting. Joint kinematics will be reconstructed from marker trajectories recorded by a camera system. Together, with EMG data, the investigators will calculate joint kinetics

  2. Muscle Activity

    Time frame: 24 months

    Retro-reflective markers will be placed on each participant in a laboratory setting. Electromyography (EMG) electrodes will be placed on the skin above the tibialis anterior, medial and lateral gastrocnemius, vastus lateralis and medialis, biceps femoris, semitendinosis and gluteus maximums of both limbs. Muscle activity will be measured using EMG signal recorded during activity.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Hip Reconstruction and Modeling for Surgical Pre-Operative Planning

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2008
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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