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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04633525
Enrollment
400
Registered
2020-11-18
Start date
2020-11-18
Completion date
2024-01-31
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthritis, Hip Osteoarthritis

Keywords

Hip Replacement, Hip Arthroplasty, Arthritis, Osteoarthritis, Hip dislocation

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.

Interventions

PROCEDUREOptimum 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.

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cup Orientation12 months after surgeryThe degree of cup inclination and anteversion as shown on X-rays

Secondary

MeasureTime frameDescription
Change in Patient Reported Function12 monthsAssess 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 Pain12 monthsAssess 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 Health12 monthsAssess the change in general health using the EQ-5D-5L
Incidence of Adverse EventsUp to 12 months after surgeryAssess safety and post-operative complications by collecting information on adverse events and serious adverse events

Countries

Canada

Contacts

Primary ContactClinical Research Coordinator
meadufresne@ohri.ca613-737-8899 x 73032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026