Hip ImplantNCT06696313
Radiographic Migration Analysis of the Insignia Hip Stem
A study testing Insignia in people with Hip Implant and Hip Replacement in Osteoarthritis Patients, run by Canadian Radiostereometric Analysis Network at 1 site in Canada.
Trial summary
The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hip Implant, Hip Replacement in Osteoarthritis Patients, Migration of Implant
- What is being tested?
- Insignia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Who cannot join
- Active or prior infection
- Medical condition precluding major surgery
- Medical condition with less than 2 years life expectancy
- Overhanging pannus (direct anterior approach)
- Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
- Skin condition on the area of incision
Show all 9Show fewer
- Multi-level lumbar spine fusion
- Ankylosing spondylolithesis
- Shortening osteotomy through the femur
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.
Read the detailed description
This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.
The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.
- Being tested
- Insignia
- Keywords
- Insignia, RSA, Total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsigniaDevice
- Insignia hip stem
- Trident hemispherical shell
- X3 polyethylene liner
- Metal or ceramic head
| Study group | Role | What they receive |
|---|---|---|
| Insignia | Other | Total hip replacement CT-RSA vs gold standard RSA Receives: Device: Insignia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration
Quantify migration of the Insignia stem using RSA and CT-RSA
Measured: Up to 2 years post-operative
Secondary outcomes (5)
Validation
Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations.
Measured: Up to 2 years post-operative
Early migration
Quantify early migration of the Trident acetabular cup using RSA
Measured: Up to 2 years post-operative
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living
Measured: Up to 2 years post-operative
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Measured: Up to 2 years post-operative
Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year
Evaluate and compare the change from preoperative to 2 years in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatified) - 100 (Completely Satisfied).
Measured: Up to 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Jan 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ImplantStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Innovation Centre
- Responsible party
- Sponsor
- Investigators
- Eric R Bohm, MD, Principal investigator, Orthopaedic Innovation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696313
- Sponsor's protocol ID
- B2024:118
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Migration Analysis of the Insignia Hip Stem
- ClinicalTrials.gov ID
- NCT06696313
- Acronym / sponsor ID
- B2024:118
- Keywords
- Insignia, RSA, Total hip replacement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Collaborators
- Orthopaedic Innovation Centre
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Nov 2024 (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 assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.
Detailed description
This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.
The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insignia | Other | Device: InsigniaTotal hip replacement CT-RSA vs gold standard RSA |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Key exclusion criteria (9 listed)
- Active or prior infection
- Medical condition precluding major surgery
- Medical condition with less than 2 years life expectancy
- Overhanging pannus (direct anterior approach)
- Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
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 |
|---|---|---|
| Insignia* Insignia hip stem * Trident hemispherical shell * X3 polyethylene liner * Metal or ceramic head | Device | Insignia |
Primary outcome
Migration
Time frame: Up to 2 years post-operative
Quantify migration of the Insignia stem using RSA and CT-RSA
5 secondary outcomes
Validation
Time frame: Up to 2 years post-operative
Early migration
Time frame: Up to 2 years post-operative
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Up to 2 years post-operative
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Up to 2 years post-operative
Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year
Time frame: Up to 2 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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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.
Eric R Bohm, MD principal investigator
Orthopaedic Innovation Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insignia in people with Hip Implant and Hip Replacement in Osteoarthritis Patients, run by Canadian Radiostereometric Analysis Network 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Migration (time frame: Up to 2 years post-operative). 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 10 Dec 2025.