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
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
November 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedFebruary 24, 2021
February 1, 2021
2.9 years
August 11, 2020
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cup Orientation
The degree of cup inclination and anteversion as shown on X-rays
12 months after surgery
Secondary Outcomes (5)
Change in Patient Reported Function
12 months
Change in Patient Reported Pain
12 months
Change in Patient Reported Health
12 months
Change in Patient Reported Health
12 months
Incidence of Adverse Events
Up to 12 months after surgery
Study Arms (1)
Optimum Cup Orientation
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.
You may not qualify if:
- Unwilling or unable to complete study requirements (either X-rays or questionnaires)
- Unwilling or unable to sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Grammatopoulos
Ottawa Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
November 18, 2020
Study Start
November 18, 2020
Primary Completion
October 1, 2023
Study Completion
January 1, 2024
Last Updated
February 24, 2021
Record last verified: 2021-02