Insignia Hip Stem for Hip Osteoarthritis

Recruiting at 11 trial locations

Overseen By Barbara Davis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Orthopaedics

Must not be taking: Steroids

Disqualifiers: Pregnancy, Infection, Neuromuscular disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: Surgery and immediate postoperative period

313 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing the safety and effectiveness of the Insignia™ Hip Stem, an artificial hip joint, in patients needing hip replacement surgery. It aims to see how well it works and how safe it is over a long period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking steroids in excess of normal physiological requirements, you may not be eligible to participate.

Is the Insignia Hip Stem safe for use in humans?

Research on uncemented femoral stems, similar to the Insignia Hip Stem, shows that they generally perform well with high survival rates over 10-15 years, indicating good safety. However, some designs may have varying results, and factors like gender can influence outcomes. ^{1 2 3 4 5}

How does the Insignia Hip Stem treatment differ from other treatments for hip osteoarthritis?

The Insignia Hip Stem is an uncemented hip replacement component, which means it does not require bone cement for fixation, potentially offering better long-term stability and reducing the risk of loosening compared to cemented options. This type of treatment is particularly beneficial for patients with good bone quality, as it allows for natural bone growth into the implant, enhancing its stability over time. ^{1 2 6 7 8}

What data supports the effectiveness of the Insignia uncemented Hip Stem treatment for hip osteoarthritis?

Research on uncemented hip stems, like the Corail stem, shows excellent long-term performance with a survival rate of 97% at 15 years, suggesting that similar uncemented stems, such as the Insignia, may also be effective for hip osteoarthritis. ^{2 7 9 10 11}

Who Is on the Research Team?

Shaherah Yancy

Principal Investigator

Stryker Joint Replacement Clinical Operations

Are You a Good Fit for This Trial?

This trial is for adults who need a new hip due to conditions like osteoarthritis, avascular necrosis, or fractures. They must be able to follow the study's schedule and have no infections around the hip. Pregnant women, those with mental/neuromuscular disorders risking implant stability, people on high-dose steroids, with allergies to implant materials, prisoners or anyone in legal disputes about their hips can't join.

Inclusion Criteria

I am a candidate for a hip replacement without cement.

The subject is willing and able to comply with postoperative scheduled clinical evaluations

I have a joint condition like osteoarthritis, rheumatoid arthritis, or I need surgery for a joint deformity or fracture.

Exclusion Criteria

The subject has a known sensitivity to device materials

I might have an infection in or near my hip where a device will be implanted.

My bones are too weak to support a new implant due to disease, infection, or previous surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total hip arthroplasty using the Insignia™ Hip Stem

Surgery and immediate postoperative period

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for safety and effectiveness of the hip stem

10 years

Visits at 6 weeks, 1, 2, 3, 4, 5, 7, and 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Insignia uncemented Hip Stem

Trial Overview The Insignia™ Hip Stem is being tested for safety and effectiveness in replacing hips damaged by arthritis, fractures or other diseases. This long-term study will track patients up to 10 years after surgery to see how well the uncemented hip stem works over time.

How Is the Trial Designed?

Group I: Insignia uncemented Hip Stem Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Stryker Orthopaedics

Lead Sponsor

Trials

79

Recruited

20,500+

Kevin A. Lobo

Stryker Orthopaedics

Chief Executive Officer since 2012

Bachelor's degree in Commerce from McGill University, MBA from University of Toronto

Dr. Jorge Enrique Diaz

Stryker Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan Medical School

Citations

1. England pubmed.ncbi.nlm.nih.gov

Medium- and long-term performance of 11,516 uncemented primary femoral stems from the Norwegian arthroplasty register. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Early aseptic loosening of uncemented femoral components in primary total hip replacement. A review based on the Norwegian Arthroplasty Register. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

"Conus" uncemented stem in developmental hip dysplasia. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Uncemented total hip arthroplasty in osteonecrosis: a 2- to 10-year evaluation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of collared and collarless femoral components in primary uncemented total hip arthroplasty. [2019]

6. France pubmed.ncbi.nlm.nih.gov

Primary total hip arthroplasty with a proximally HA-coated titanium femoral component: results at 10-15-year follow-up. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Subsidence of collarless uncemented femoral stems in total hips replacements performed for trauma. [2016]

8. Sweden pubmed.ncbi.nlm.nih.gov

Similar outcome with a new anteverted or a straight standard stem: a randomized study of 72 total hip arthroplasties evaluated with clinical variables, radiostereometry, and DXA up to 2 years. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Short versus conventional stem in cementless total hip arthroplasty : An evidence-based approach with registry data of mid-term survival. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Outcome of uncemented primary femoral stems for treatment of femoral head osteonecrosis. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

High survival of uncemented proximally porous-coated titanium alloy femoral stems in osteoporotic bone. [2022]