What side effects are associated with this type of intervention?

Common treatments for femoral neck fractures often involve hip replacement using prosthetic devices such as the Insignia™ Hip Stem. Known side effects of these treatments include surgical complications like infection, blood clots, and prosthetic dislocation. Postoperative issues may include pain, limited mobility, and the potential for prosthetic loosening or wear over time. Additionally, there is a risk of nerve damage and differences in leg length following surgery.

What prior FDA approvals exist?

The FDA has approved several prosthetic devices for the treatment of femoral neck fractures, including various hip replacement systems. These devices, such as the Insignia™ Hip Stem, are designed to replace the damaged femoral head and neck, providing stability and restoring function. Additionally, pharmacological treatments like bisphosphonates (e.g., alendronate, zoledronic acid) and anabolic agents (e.g., teriparatide) are often used to enhance bone healing and prevent further fractures in patients with osteoporosis, which is a common underlying condition in those suffering from femoral neck fractures.

What other types of research exist?

Promising novel alternatives to the Insignia™ Hip Stem for femoral neck fracture patients in 2024 include: 1) 3D-printed customized titanium prostheses, which offer personalized fit and improved biomechanical properties; 2) Modular hemipelvic prostheses, which provide flexibility in reconstruction and better functional outcomes; and 3) Advanced ceramic-on-ceramic or ceramic-on-polyethylene hip implants, which reduce wear and increase longevity of the prosthesis. These alternatives have shown potential in recent studies for enhanced patient outcomes and durability.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-op, 6 week, 1,2,3, 4,5,7 and 10 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

EQ-5D - Descriptive System

EQ-5D - Visual analogue scale (VAS)

Harris Hip Score (HHS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

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.