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
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.
- 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