Hip OsteoarthritisNCT05144191
Insignia™ Hip Stem Outcomes Study
A study testing Insignia uncemented Hip Stem in people with Hip Osteoarthritis and Avascular Necrosis, run by Stryker Orthopaedics at 11 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- What is being tested?
- Insignia uncemented Hip Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 11 sitesUnited States
- Study dates
- 7 Feb 2022to 2 Apr 2034
- 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 subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
- The subject is skeletally mature
- The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
- The subject is a candidate for a primary or revision cementless THA.
- The subject is willing and able to comply with postoperative scheduled clinical evaluations.
Who cannot join
- The subject is pregnant or breastfeeding
- The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
- The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- The subject has a known sensitivity to device materials.
- The subject is involved in any ongoing legal matter, investigation, or dispute pertaining to the operative site.
- The subject is a prisoner.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Northwell Health: University Orthopaedic Associates
Great Neck, New York, 11021
TOA Research Foundation
Nashville, Tennessee, 37204
The MORE Foundation
Phoenix, Arizona, 85023
Alleghany Health Network- Research Institute
Pittsburgh, Pennsylvania, 15212
Reno Orthopedic Center Foundation
Reno, Nevada, 89503
University of California, San Francisco
San Francisco, California, 94158
Orthopedic Physician Associates
Seattle, Washington, 98122
Providence Orthopedics and Sports Medicine
Spokane, Washington, 99208
Baylor Scott and White Medical Center
Temple, Texas, 76508
About this study
Official title: Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery
The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
Read the detailed description
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
- Conditions
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures
- Being tested
- Insignia uncemented Hip Stem
- Medical subject headings
- Osteoarthritis, Hip, Osteonecrosis, Arthritis, Rheumatoid, Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insignia uncemented Hip StemDevice
Device: Replacement of arthritic hip with Insignia uncemented Hip Stem
| Study group | Role | What they receive |
|---|---|---|
| Insignia uncemented Hip Stem | Other | The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside.
Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures. Receives: Device: Insignia uncemented Hip Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
Measured: 10 years
Harris Hip Score (HHS)
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion.
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score.
A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Measured: 10 Years
Secondary outcomes (4)
Harris Hip Score (HHS)
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion.
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score.
A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
Measured: pre-op, 6 week, 1,2,5 and 7 years
EQ-5D - Descriptive System
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values.
The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.
Measured: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
EQ-5D - Visual analogue scale (VAS)
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values.
With the EQ Visual Analogue Scale (VAS) the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
Survival Rate
Evaluation of the survival rate for Insignia™ Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture
Success rate at two (2) years postoperative with the Insignia™ Hip Stem is not worse than 98 % with a non-inferiority margin of 3.5%.
Success rate at 10 years postoperative with the Insignia™ Hip Stem is not worse than 95% with a non-inferiority margin of 5%.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start7 Feb 2022
- Primary completion2 Apr 2034 (estimated)
- Study completion2 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Orthopaedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144191
- Sponsor's protocol ID
- 107
- Status last verified
- May 2026
- First submitted
- 3 Nov 2021
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insignia™ Hip Stem Outcomes Study - A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia™ Hip Stem for Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT05144191
- Acronym / sponsor ID
- 107
- Conditions
- Hip Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Femoral Neck Fractures, Trochanteric Fractures
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Stryker OrthopaedicsIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 2 Apr 2034 (estimated)
- Study completion
- 2 Apr 2034 (estimated)
- First posted
- 3 Dec 2021 (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 objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.
Detailed description
This study is a prospective, post-market, multi-center clinical investigation of the Insignia™ Hip Stem for primary and revision total hip arthroplasty (THA) in a consecutive series of patients who meet the eligibility criteria. The total enrollment goal for the study is a minimum of 313 cases, all of which will receive the Insignia™ Hip Stem.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insignia uncemented Hip Stem | Other | Device: Insignia uncemented Hip StemThe Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Insignia™ Hip Stems are intended for 'cement less' use only and are intended for total arthroplasty procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject has signed an Institutional Review Board (IRB)-approved, study specific Informed Consent Form (ICF).
- The subject is skeletally mature
- The subject has a diagnosis as listed in the instructions for use (IFU), which include non inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis, correction of functional deformity, treatment of nonunion, femoral neck and trochanteric fractures.
- The subject is a candidate for a primary or revision cementless THA.
- The subject is willing and able to comply with postoperative scheduled clinical evaluations.
Key exclusion criteria (8 listed)
- The subject is pregnant or breastfeeding
- The subject has an active or suspected latent infection in or about the affected hip joint at the time of study device implantation.
- The subject has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- The subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
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 uncemented Hip StemDevice: Replacement of arthritic hip with Insignia uncemented Hip Stem | Device | Insignia uncemented Hip Stem |
Primary outcome
Survival Rate
Time frame: 10 years
Evaluation of the survival rate for Insignia Hip Stem is defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture.
Harris Hip Score (HHS)
Time frame: 10 Years
The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor
4 secondary outcomes
Harris Hip Score (HHS)
Time frame: pre-op, 6 week, 1,2,5 and 7 years
EQ-5D - Descriptive System
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
EQ-5D - Visual analogue scale (VAS)
Time frame: pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
Survival Rate
Time frame: 2 years
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 18 May 2026.
- 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insignia uncemented Hip Stem in people with Hip Osteoarthritis and Avascular Necrosis, run by Stryker Orthopaedics at 11 sites in United States.
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 5 inclusion and 8 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Survival Rate (time frame: 10 years). The study lists 2 primary outcomes in all. 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 18 May 2026.