Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))NCT06108934
A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
A study testing Hip stem prosthesis in people with Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA)), run by Stryker Australia Pty Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
- What is being tested?
- Hip stem prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Feb 2024to Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
- Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
- The patient is a candidate for a primary cementless THA.
- Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Who cannot join
- Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
- Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.)
- Requires revision THA or hip fusion to the affected joint.
- Has known sensitivity to device materials.
- Any involvement in an active Workers' Compensation investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Gavin Clark, MD, +61 8 64891777, clark@hipnknee.com.au
About this study
Official title: A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery.
It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.
- Conditions
- Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
- Being tested
- Hip stem prosthesis
- Medical subject headings
- Arthritis, Joint Diseases, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip stem prosthesisDevice
The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Insignia hip stem study group Receives: Device: Hip stem prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
Measured: 2 years post-operatively
Secondary outcomes (9)
Oxford Hip Score
Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group
Measured: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Hip Disability and Osteoarthritis Outcome Score (HOOS-12).
Function, pain and satisfaction in the intervention group using the Hip Disability and Osteoarthritis Outcome Score mid-version (HOOS-12). This is a composite measure.
Measured: Pre-operatively and 6 months, 12 months and 2 years post-operatively
EQ-5D-5L
Function, pain and satisfaction in the intervention group using EQ-5D-5L domains and EQ (Visual analogue scale) VAS. This is a composite measure.
Measured: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Hip and lower back pain VAS
Hip and lower back pain in the intervention group using a VAS. This is a composite measure.
Measured: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Forgotten Joint Score (FJS)
Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure.
Measured: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Complications
Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group..
Measured: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
Mortality
Mortality in the intervention group
Measured: 1 and 2 years post-operatively
CPR for stem loosening
CPR of the Insignia Hip Stem for stem loosening in the intervention group
Measured: 2 years post-operatively
Femoral fracture
Insignia Hip Stem device-related femoral fracture in the intervention group
Measured: 2 years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start22 Feb 2024
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))Studies 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
- 313 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gavin Clark, MD, Principal investigator, Perth Hip and Knee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108934
- Sponsor's protocol ID
- Insignia-23
- Status last verified
- May 2025
- First submitted
- 18 Oct 2023
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
- ClinicalTrials.gov ID
- NCT06108934
- Acronym / sponsor ID
- Insignia-23
- Conditions
- Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 313 participants (estimated)
- Lead sponsor
- Stryker Australia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Oct 2023 (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 evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery.
It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Hip stem prosthesisInsignia hip stem study group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device
- Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis
- The patient is a candidate for a primary cementless THA.
- Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period.
Key exclusion criteria (7 listed)
- Active or suspected latent infection in or about the affected hip joint and the time of study device implantation.
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care.
- Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.)
- Requires revision THA or hip fusion to the affected joint.
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 |
|---|---|---|
| Hip stem prosthesisThe Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis. | Device | Intervention group |
Primary outcome
Implant survivorship
Time frame: 2 years post-operatively
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
9 secondary outcomes
Oxford Hip Score
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Hip Disability and Osteoarthritis Outcome Score (HOOS-12).
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
EQ-5D-5L
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Hip and lower back pain VAS
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Forgotten Joint Score (FJS)
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
Complications
Time frame: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
Mortality
Time frame: 1 and 2 years post-operatively
CPR for stem loosening
Time frame: 2 years post-operatively
Femoral fracture
Time frame: 2 years post-operatively
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 15 May 2025.
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.
Gavin Clark, MD principal investigator
Perth Hip and Knee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip stem prosthesis in people with Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA)), run by Stryker Australia Pty Ltd. at 1 site in Australia.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 May 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 Australia. 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?
Contact Holly Solomon (+61405307762, holly.solomon@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survivorship (time frame: 2 years post-operatively). 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 15 May 2025.