Dynamic Imaging of the Hip for Pre-operative Planning

Femoroacetabular, Impingement Clinical Trial

Official title:

Hip Reconstruction and Modeling for Surgical Pre-Operative Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605969
• Other study ID #: 2006-552
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoroacetabular, Impingement

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Brisson N, Lamontagne M, Kennedy MJ, Beaulé 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. — View Citation

Kennedy MJ, Lamontagne M, Beaulé 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. — View Citation

Lamontagne M, Brisson N, Kennedy MJ, Beaulé 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 — View Citation

Lamontagne M, Kennedy MJ, Beaulé 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. — View Citation

Ng KC, Lamontagne M, Adamczyk AP, Rakhra KS, Beaulé 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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