Hip ArthritisNCT04633525
Defining Optimum Cup Orientation for Hip Replacements Taking Into Account the Individual's Anatomy and Movement Patterns
A study testing Optimum Cup Orientation in people with Hip Arthritis and Hip Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Arthritis, Hip Osteoarthritis
- What is being tested?
- Optimum Cup Orientation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 18 Nov 2020to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.
Who cannot join
- Unwilling or unable to complete study requirements (either X-rays or questionnaires)
- Unwilling or unable to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Meaghan Dufresne, meadufresne@ohri.ca
George Grammatopoulos
About this study
Official title: A Prospective Study to Define Optimum Cup Orientation in Hip Arthroplasty Accounting for the Individual's Anatomy and Movement Patterns
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
- Being tested
- Optimum Cup Orientation
- Keywords
- Hip Replacement, Hip Arthroplasty, Arthritis, Osteoarthritis, Hip dislocation
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Osteoarthritis, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimum Cup OrientationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimum Cup Orientation | Experimental | Not described Receives: Procedure: Optimum Cup Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cup Orientation
The degree of cup inclination and anteversion as shown on X-rays
Measured: 12 months after surgery
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
Change in Patient Reported Health
Assess the change in general health using the EQ-5D-5L
Measured: 12 months
Change in Patient Reported Health
Assess the change in general health using the PROMIS-15
Measured: 12 months
Incidence of Adverse Events
Assess safety and post-operative complications by collecting information on adverse events and serious adverse events
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start18 Nov 2020
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Grammatopoulos, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633525
- Sponsor's protocol ID
- 2251
- Status last verified
- Feb 2021
- First submitted
- 11 Aug 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Define Optimum Cup Orientation in Hip Arthroplasty Accounting for the Individual's Anatomy and Movement Patterns
- ClinicalTrials.gov ID
- NCT04633525
- Acronym / sponsor ID
- 2251
- Conditions
- Hip Arthritis, Hip Osteoarthritis
- Keywords
- Hip Replacement, Hip Arthroplasty, Arthritis, Osteoarthritis, Hip dislocation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimum Cup Orientation | Experimental | Procedure: Optimum Cup Orientation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Signed up for primary total hip arthroplasty procedures at the General Campus at The Ottawa Hospital.
Key exclusion criteria (2 listed)
- Unwilling or unable to complete study requirements (either X-rays or questionnaires)
- Unwilling or unable to sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimum Cup OrientationParticipants 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. | Procedure or surgery | Optimum Cup Orientation |
Primary outcome
Cup Orientation
Time frame: 12 months after surgery
The degree of cup inclination and anteversion as shown on X-rays
5 secondary outcomes
Change in Patient Reported Function
Time frame: 12 months
Change in Patient Reported Pain
Time frame: 12 months
Change in Patient Reported Health
Time frame: 12 months
Change in Patient Reported Health
Time frame: 12 months
Incidence of Adverse Events
Time frame: Up to 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Grammatopoulos principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimum Cup Orientation in people with Hip Arthritis and Hip Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (613-737-8899 x 73032, meadufresne@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cup Orientation (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.