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Hip Stem

Insignia Hip Stem for Hip Osteoarthritis

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.

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

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor

77 Previous Clinical Trials

19,920 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for enrolment in this clinical trial?

"Clinicaltrials.gov reveals that enrollment is currently open for this investigation, which was first announced on February 7th 2022 and was most recently amended on August 26th of the same year."

Answered by AI

What is the maximum amount of participants that can join this trial?

"Affirmative. According to clinicaltrials.gov, this study commenced on February 7th 2022 and is still actively recruiting participants. A total of 313 individuals are needed for the trial which will take place at two distinct locations."

Answered by AI