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

Primary Purpose

Hip Arthritis, Hip Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Optimum Cup Orientation

About this trial

This is an interventional treatment trial for Hip Arthritis focused on measuring Hip Replacement, Hip Arthroplasty, Arthritis, Osteoarthritis, Hip dislocation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optimum Cup Orientation

Arm Description

Outcomes

Primary Outcome Measures

Cup Orientation

The degree of cup inclination and anteversion as shown on X-rays

Secondary Outcome Measures

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.

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.

Change in Patient Reported Health

Assess the change in general health using the EQ-5D-5L

Change in Patient Reported Health

Assess the change in general health using the PROMIS-15

Incidence of Adverse Events

Assess safety and post-operative complications by collecting information on adverse events and serious adverse events

Full Information

NCT ID

NCT04633525

First Posted

August 11, 2020

Last Updated

February 22, 2021

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04633525

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 18, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Arthritis, Hip Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Optimum Cup Orientation

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Optimum Cup Orientation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cup Orientation

Description

The degree of cup inclination and anteversion as shown on X-rays

Time Frame

12 months after surgery

Secondary Outcome Measure Information:

Title

Change in Patient Reported Function

Description

Assess the change in function using the Oxford Hip Score. Total scores range from 0-48. The higher the score, the better the outcome.

Time Frame

12 months

Title

Change in Patient Reported Pain

Description

Assess the change in pain using the Oxford Hip Score. Total scores range from 0-48. The higher the score, the better the outcome.

Time Frame

12 months

Title

Change in Patient Reported Health

Description

Assess the change in general health using the EQ-5D-5L

Time Frame

12 months

Title

Change in Patient Reported Health

Description

Assess the change in general health using the PROMIS-15

Time Frame

12 months

Title

Incidence of Adverse Events

Description

Assess safety and post-operative complications by collecting information on adverse events and serious adverse events

Time Frame

Up to 12 months after surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Research Coordinator

Phone

613-737-8899 x 73032

meadufresne@ohri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Grammatopoulos

Organizational Affiliation

Ottawa Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meaghan Dufresne

meadufresne@ohri.ca

First Name & Middle Initial & Last Name & Degree

George Grammatopoulos

12. IPD Sharing Statement

Learn more about this trial

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

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