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

Not Applicable

• Conditions: Hip Arthritis; Hip Osteoarthritis
• Interventions: Procedure: Optimum Cup Orientation

• Registration Number: NCT04633525
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-11-12
• Study Start: 2020-11-18
• Study First Posted: 2020-11-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24
• Primary Completion: 2023-10
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimum Cup Orientation	Optimum Cup Orientation	-

Primary Outcome Measures

Name	Time	Method
Cup Orientation	12 months after surgery	The degree of cup inclination and anteversion as shown on X-rays

Secondary Outcome Measures

Name	Time	Method
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 PROMIS-15
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.
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

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada