Total Hip ArthroplastyINSTHANCT05416463
Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
A study testing Intra-Operative Device for THA in people with Total Hip Arthroplasty, run by Waterloo Regional Health Network.
Trial summary
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Intra-Operative Device for THA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving primary THA
- Elective THA
- Provision of informed consent
Who cannot join
- Unable to obtain informed consent
- Receiving revision THA
- THA is to treat trauma (i.e. hip fracture and/or dislocation)
- Patient is undergoing simultaneous bilateral hip replacement
- Performing surgeon is not participating in the study
- Hip fracture
Show all 13Show fewer
- Hip dislocation
- Severe osteoporosis
- Trochanteric osteotomy
- Suspected or actual infection
- Existing implanted hardware
- Severe deformities of the femoral or pelvic bone
- High Body Mass Index (BMI)*
About this study
Official title: A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Intra-Operative Device for THA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Operative Device for THAProcedure or surgery
The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | The control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery Receives: Procedure: Intra-Operative Device for THA |
| Treatment | Experimental | The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool. Receives: Procedure: Intra-Operative Device for THA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Living
Hip disability and Osteoarthritis Outcome Score (HOOS)
Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a "HOOS profile".
"0 indicates extreme problems and 100 indicates no problems."
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waterloo Regional Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416463
- Sponsor's protocol ID
- INSTHA
- Acronym
- INSTHA
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05416463
- Acronym / sponsor ID
- INSTHA / INSTHA
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Waterloo Regional Health NetworkUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Jun 2022 (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.
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: Intra-Operative Device for THAThe control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery |
| Treatment | Experimental | Procedure: Intra-Operative Device for THAThe intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving primary THA
- Elective THA
- Provision of informed consent
Key exclusion criteria (13 listed)
- Unable to obtain informed consent
- Receiving revision THA
- THA is to treat trauma (i.e. hip fracture and/or dislocation)
- Patient is undergoing simultaneous bilateral hip replacement
- Performing surgeon is not participating in the study
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 |
|---|---|---|
| Intra-Operative Device for THAThe intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool. | Procedure or surgery | Control, Treatment |
Primary outcome
Activities of Daily Living
Time frame: up to 12 months
Hip disability and Osteoarthritis Outcome Score (HOOS) Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a "HOOS profile". "0 indicates extreme problems and 100 indicates no problems."
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Operative Device for THA in people with Total Hip Arthroplasty, run by Waterloo Regional Health Network.
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 3 inclusion and 13 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 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activities of Daily Living (time frame: up to 12 months). 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 13 Jun 2022.