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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04633525

Collaborator

(none)

400

Enrollment

Location

Arm

37.4

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthritis Hip Osteoarthritis	Procedure: Optimum Cup Orientation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optimum Cup Orientation	Procedure: Optimum Cup Orientation 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.

Arm

Intervention/Treatment

Experimental: Optimum Cup Orientation

Procedure: Optimum Cup Orientation

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.

Outcome Measures

Primary Outcome Measures

Cup Orientation [12 months after surgery]
The degree of cup inclination and anteversion as shown on X-rays

Secondary Outcome Measures

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