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

NCT ID: NCT04633525

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2024-01-31

Brief Summary

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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

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Conditions

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Hip Arthritis Hip Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optimum Cup Orientation

Group Type EXPERIMENTAL

Optimum Cup Orientation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Grammatopoulos

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Clinical Research Coordinator

Role: CONTACT

613-737-8899 x 73032

Facility Contacts

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Meaghan Dufresne

Role: primary

Other Identifiers

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2251

Identifier Type: -

Identifier Source: org_study_id

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