Dynamic Imaging of the Hip for Pre-operative Planning

Hip Reconstruction and Modeling for Surgical 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.

Study Overview

• Status: Completed
• Conditions: Femoroacetabular, Impingement
• Intervention / Treatment: Procedure: Motion analysis; Diagnostic test: Computed Tomography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FAI patients; This group consists of participants diagnosed with femoroacetabular impingement that are undergoing surgical correction.	Procedure: Motion analysis; Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.; Diagnostic test: Computed Tomography; Participants will undergo computed tomography (CT) scan of their hip.
Placebo Comparator: Control; This group consists of healthy control participants with no hip problems.	Procedure: Motion analysis; Participants will undergo a motion analysis procedure: a dynamic assessment of the movement in their hip.; Diagnostic test: Computed Tomography; Participants will undergo computed tomography (CT) scan of their hip.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of kinematic model of hip joint	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.	Within 6 months of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint Kinetics	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	24 months
Muscle Activity	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.	24 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Ng KC, Lamontagne M, Adamczyk AP, Rakhra KS, Beaule PE. Patient-specific anatomical and functional parameters provide new insights into the pathomechanism of cam FAI. Clin Orthop Relat Res. 2015 Apr;473(4):1289-96. doi: 10.1007/s11999-014-3797-1. Erratum In: Clin Orthop Relat Res. 2014 Dec;472(12):4045. Rahkra, Kawan S [corrected to Rakhra, Kawan S].
• Kennedy MJ, Lamontagne M, Beaule PE. Femoroacetabular impingement alters hip and pelvic biomechanics during gait Walking biomechanics of FAI. Gait Posture. 2009 Jul;30(1):41-4. doi: 10.1016/j.gaitpost.2009.02.008.
• Lamontagne M, Kennedy MJ, Beaule PE. The effect of cam FAI on hip and pelvic motion during maximum squat. Clin Orthop Relat Res. 2009 Mar;467(3):645-50. doi: 10.1007/s11999-008-0620-x. Epub 2008 Nov 26.
• Lamontagne M, Brisson N, Kennedy MJ, Beaule PE. Preoperative and postoperative lower-extremity joint and pelvic kinematics during maximal squatting of patients with cam femoro-acetabular impingement. J Bone Joint Surg Am. 2011 May;93 Suppl 2:40-5. doi: 10.2106/JBJS.J.01809.
• Brisson N, Lamontagne M, Kennedy MJ, Beaule PE. The effects of cam femoroacetabular impingement corrective surgery on lower-extremity gait biomechanics. Gait Posture. 2013 Feb;37(2):258-63. doi: 10.1016/j.gaitpost.2012.07.016. Epub 2012 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 21, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 1, 2008

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: femoroacetabular, impingement
• Other Study ID Numbers: 2006-552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No