Primary Total Hip ArthroplastyNCT05313321
Survival of the Insignia Stem in Total Hip Arthroplasty
An observational study of Primary Total Hip Arthroplasty, run by University of Utah at 1 site in United States.
Trial summary
The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- Primary total hip arthroplasty receiving the Insignia Stem
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2022to Mar 2028
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planning on undergoing primary total hip arthroplasty
Who may be able to join
- Patients age ≥18
- Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.
- Preoperative diagnosis of osteoarthritis
- Patients willing and able to comply with follow-up requirements
- Patients willing to sign an IRB approved consent and authorization document
Who cannot join
- Patients with inflammatory or pyogenic arthritis
- Body Mass Index (BMI)>40
- Bone stock that is inadequate for support or fixation of the prosthesis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty
The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm.
Read the detailed description
Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).
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. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- Primary total hip arthroplasty receiving the Insignia Stem
- Keywords
- Primary Total Hip Arthroplasty, Insignia™ Hip Stem, Radiographic review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary total hip arthroplasty receiving the Insignia StemDevice
Also called Total Hip Arthroplasty
Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Primary total hip arthroplasty receiving the Insignia Stem | Patients undergoing primary total hip arthroplasty that will likely receive the Insignia Stem and associated Stryker Acetabular Component. Receives: Device: Primary total hip arthroplasty receiving the Insignia Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographs review
Reviewing radiographic radiolucent lines <2mm
Measured: Pre-operative
Radiographs review
Reviewing radiographic radiolucent lines <2mm
Measured: 6-weeks post-operative
Radiographs review
Reviewing radiographic radiolucent lines <2mm
Measured: 1-year post-operative
Radiographs review
Reviewing radiographic radiolucent lines <2mm
Measured: 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 posted6 Apr 2022
- Study start17 Mar 2022
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Anderson, University of Utah
- Investigators
- Lucas Anderson, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313321
- Sponsor's protocol ID
- 145076
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05313321
- Acronym / sponsor ID
- 145076
- Conditions
- Primary Total Hip Arthroplasty
- Keywords
- Primary Total Hip Arthroplasty, Insignia™ Hip Stem, Radiographic review
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 6 Apr 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.
The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm.
Detailed description
Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).
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. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary total hip arthroplasty receiving the Insignia Stem | – | Device: Primary total hip arthroplasty receiving the Insignia StemPatients undergoing primary total hip arthroplasty that will likely receive the Insignia Stem and associated Stryker Acetabular Component. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planning on undergoing primary total hip arthroplasty
Key inclusion criteria (5 listed)
- Patients age ≥18
- Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.
- Preoperative diagnosis of osteoarthritis
- Patients willing and able to comply with follow-up requirements
- Patients willing to sign an IRB approved consent and authorization document
Key exclusion criteria (3 listed)
- Patients with inflammatory or pyogenic arthritis
- Body Mass Index (BMI)>40
- Bone stock that is inadequate for support or fixation of the prosthesis
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 |
|---|---|---|
| Primary total hip arthroplasty receiving the Insignia StemAlso: Total Hip ArthroplastyPatients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty | Device | Primary total hip arthroplasty receiving the Insignia Stem |
Primary outcome
Radiographs review
Time frame: Pre-operative
Reviewing radiographic radiolucent lines <2mm
Radiographs review
Time frame: 6-weeks post-operative
Reviewing radiographic radiolucent lines <2mm
Radiographs review
Time frame: 1-year post-operative
Reviewing radiographic radiolucent lines <2mm
Radiographs review
Time frame: 2-years post-operative
Reviewing radiographic radiolucent lines <2mm
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 1 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Total Hip Arthroplasty
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DEXA Bone Density Analysis of the CoreHip® Prosthesis System
Primary Osteoarthritis, Cartilage Degeneration
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Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
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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.
Lucas Anderson, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Total Hip Arthroplasty, run by University of Utah at 1 site 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 3 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 1 Sep 2026. 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 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?
Radiographs review (time frame: Pre-operative). The study lists 4 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 1 Sep 2026.