Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04633525

Conditions

Hip Arthritis

Hip Osteoarthritis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Optimum Cup Orientation

Study Details

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.

Conditions

Hip Arthritis

Hip Osteoarthritis

Study ID

NCT04633525

Start date

Nov 18, 2020

Status verified date

Feb, 2021

Completion date

Jan, 2024

Anticipated

Primary completion date

Oct, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Optimum Cup Orientation

Interventions

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.

Primary outcome measure

  • Cup Orientation [ Time Frame: 12 months after surgery ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

613-737-8899 x 73032meadufresne@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Meaghan Dufresne

meadufresne@ohri.ca

Principal Investigator:

George Grammatopoulos

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 24, 2021

Last verified

Feb, 2021

Keywords

  • Hip Replacement
  • Hip Arthroplasty
  • Arthritis
  • Osteoarthritis
  • Hip dislocation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2021-02-24.