Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns

Study Overview
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Brief Summary
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The purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. Enrolled participants will have a series of X-rays analyzed before surgery to identify their individual optimal zone or cup orientation. This information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. Follow-up X-rays taken after surgery will determine if the cup is within the suggested optimal zone. Questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after surgery.

Official Title
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A Prospective Study to Define Optimum Cup Orientation in Hip Arthroplasty Accounting for the Individual's Anatomy and Movement Patterns

Conditions
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Hip Arthritis, Hip Osteoarthritis

Intervention / Treatment
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* Procedure: Optimum Cup Orientation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital. Exclusion Criteria: Unwilling or unable to complete study requirements (either X-rays or questionnaires) Unwilling or unable to sign the informed consent form
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimum Cup Orientation<br> | Procedure: Optimum Cup Orientation<br>* Participants will have X-rays taken before surgery to determine the target optimal zone for orientation of the cup implant, using EBRA software. The surgeon may or may not implant in this target zone, depending on what they believe is in the patient's best interest. X-rays will be taken at 12 months after surgery to determine if they target cup orientation was achieved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cup Orientation | The degree of cup inclination and anteversion as shown on X-rays | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Reported Function | Assess the change in function using the Oxford Hip Score. Total scores range from 0-48. The higher the score, the better the outcome. | 12 months | 
| Change in Patient Reported Pain | Assess the change in pain using the Oxford Hip Score. Total scores range from 0-48. The higher the score, the better the outcome. | 12 months | 
| Change in Patient Reported Health | Assess the change in general health using the EQ-5D-5L | 12 months | 
| Change in Patient Reported Health | Assess the change in general health using the PROMIS-15 | 12 months | 
| Incidence of Adverse Events | Assess safety and post-operative complications by collecting information on adverse events and serious adverse events | Up to 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Replacement, Hip Arthroplasty, Arthritis, Osteoarthritis, Hip dislocation