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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04633525
• Other study ID #: 2251
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: January 2024

Study information

• Verified date: February 2021
• Source: Ottawa Hospital Research Institute
• Contact: Clinical Research Coordinator
• Phone: 613-737-8899 x 73032
• Email: meadufresne[@]ohri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis
• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cup Orientation	The degree of cup inclination and anteversion as shown on X-rays	12 months after surgery
Secondary	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
Secondary	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
Secondary	Change in Patient Reported Health	Assess the change in general health using the EQ-5D-5L	12 months
Secondary	Change in Patient Reported Health	Assess the change in general health using the PROMIS-15	12 months
Secondary	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