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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Osteoarthritis; Hip Arthritis
• Intervention / Treatment: Procedure: Optimum Cup Orientation

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 613-737-8899 x 73032; Email: meadufresne@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Meaghan Dufresne; Email: meadufresne@ohri.ca
      • Principal Investigator: George Grammatopoulos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: George Grammatopoulos, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Hip Arthroplasty; Hip Replacement; Hip dislocation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No