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Hip Stem

Insignia Hip Stem for Hip Osteoarthritis

N/A
Waitlist Available
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject is a candidate for a primary or revision cementless THA
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
Must not have
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 bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
Awards & highlights

Summary

This trial is looking at the safety and effectiveness of a hip stem over a ten year period.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection risks associated with any surgical procedure, possible inflammation around the new joint, allergic reactions if sensitive to materials used in the implant and complications that could lead to further surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for a hip replacement without cement.
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I have a joint condition like osteoarthritis, rheumatoid arthritis, or I need surgery for a joint deformity or fracture.
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My bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I might have an infection in or near my hip where a device will be implanted.
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My bones are too weak to support a new implant due to disease, infection, or previous surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op, 6 week, 1,2,3, 4,5,7 and 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op, 6 week, 1,2,3, 4,5,7 and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
EQ-5D - Descriptive System
EQ-5D - Visual analogue scale (VAS)
Harris Hip Score (HHS)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Insignia uncemented Hip StemExperimental Treatment1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for femoral neck fractures, such as hip replacement procedures using prosthetic devices like the Insignia™ Hip Stem, work by replacing the damaged femoral head and neck with a prosthetic implant. This treatment restores mobility and function, alleviates pain, and improves joint stability, allowing patients to return to their daily activities. The prosthetic device mimics the natural anatomy of the hip, providing a durable and functional joint replacement, which is crucial for improving the quality of life for femoral neck fracture patients.

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,122 Total Patients Enrolled
Shaherah YancyStudy DirectorStryker Joint Replacement Clinical Operations

Media Library

Insignia uncemented Hip Stem (Hip Stem) Clinical Trial Eligibility Overview. Trial Name: NCT05144191 — N/A
Femoral Neck Fracture Research Study Groups: Insignia uncemented Hip Stem
Femoral Neck Fracture Clinical Trial 2023: Insignia uncemented Hip Stem Highlights & Side Effects. Trial Name: NCT05144191 — N/A
Insignia uncemented Hip Stem (Hip Stem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144191 — N/A
~209 spots leftby Apr 2034