Insignia Hip Stem for Hip Osteoarthritis

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of a new hip implant called the Insignia Hip Stem for individuals with hip problems such as osteoarthritis. The Insignia Hip Stem is designed for use without cement, potentially improving hip function after surgery. This trial suits those with hip issues like osteoarthritis or fractures who plan to undergo hip replacement surgery. Participants must attend follow-up appointments after their surgery. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance future hip replacement procedures.

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.

What prior data suggests that the Insignia Hip Stem is safe for hip osteoarthritis?

Research on uncemented femoral stems, such as the Insignia Hip Stem, shows that these implants generally last well for 10 to 15 years. This suggests they are dependable and compatible with the body. Early studies indicate that the Insignia Hip Stem is safe and effective shortly after surgery, with few complications. Overall, evidence suggests that the Insignia Hip Stem is a promising option for those considering hip replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Insignia uncemented Hip Stem is unique because it features a specialized coating that enhances bone integration. Unlike traditional cemented hip replacements, which use cement to secure the implant, this hip stem uses a plasma-sprayed Hydroxyapatite (HA) coating over titanium and a grit-blasted surface to promote natural bone growth and stability without cement. Researchers are excited about this treatment because it could lead to more durable and long-lasting hip replacements, reducing the need for revision surgeries and improving patient outcomes in those with hip osteoarthritis.

What evidence suggests that the Insignia Hip Stem is effective for hip osteoarthritis?

Research shows that the Insignia™ Hip Stem, a cementless hip implant, holds promise for treating hip osteoarthritis. Studies have found it to be over 98% effective two years post-surgery. This implant typically lasts 10 to 15 years. Compared to other hip implants, the Insignia Hip Stem's design often performs better, particularly for younger patients. These findings suggest that the Insignia Hip Stem is a reliable choice for those needing hip replacement. ^{2 3 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05144191

NCT05144191 | Insignia™ Hip Stem Outcomes Study 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 ...

2. withpower.com withpower.com/trial/phase-femoral-neck-fractures-2022-42bfb

Insignia Hip Stem for Hip Osteoarthritis · Info for Participants 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4133466/

Survival outcomes of cemented compared to uncemented ... Hybrid fixation also showed poorer survival in the under 55 year group compared to uncemented THR (1.03/100 cy compared to 0.93/100 cy, P < 0.002) suggesting ...

4. trial.medpath.com trial.medpath.com/clinical-trial/b83ec4daea10a26f/nct05144191-insignia-hip-stem-outcomes-study

Insignia™ Hip Stem Outcomes Study - MedPath 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124001894

Outcomes of Primary Total Hip Arthroplasty Using Custom ... The mean intraoperative fracture rate was 3.23% (95% CI: 1.35-5.11), and the mean postoperative leg length discrepancy was 4.25 mm (95% CI: 1.57-6.93). The mean ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540325003286

Early Outcomes Following Total Hip Arthroplasty With a ... The recently introduced femoral stem appears to be a safe and effective implant option in the short-term postoperative period, resulting in low complication ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05144191

Insignia™ Hip Stem Outcomes Study - UCSF Clinical Trials The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11546925/

Challenges and Long-Term Outcomes of Cementless Total ... A 24-year follow-up study with a minimum 8-year follow-up, focused on developmental dysplasia of the hip.