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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 belowSelect...
I am a candidate for a hip replacement without cement.
Select...
I have a joint condition like osteoarthritis, rheumatoid arthritis, or I need surgery for a joint deformity or fracture.
Select...
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
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 moreTrial 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.
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Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,120 Total Patients Enrolled
Shaherah YancyStudy DirectorStryker Joint Replacement Clinical Operations
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have an infection in or near my hip where a device will be implanted.I am a candidate for a hip replacement without cement.I have a joint condition like osteoarthritis, rheumatoid arthritis, or a similar diagnosis.I have a joint condition like osteoarthritis, rheumatoid arthritis, or I need surgery for a joint deformity or fracture.My bones have stopped growing.My bones are too weak to support a new implant due to disease, infection, or previous surgery.I am on long-term steroids or have a weakened immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Insignia uncemented Hip Stem
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What site did they apply to?
Toomey Orthopedic Research Institute, PLLC
What portion of applicants met pre-screening criteria?
Met criteria
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