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Joint Replacement

Restoration ADM X3 Device for Hip Replacement

N/A
Waitlist Available
Led By Amit Atrey, MD
Research Sponsored by Stryker Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
Patient is a candidate for a primary cementless acetabular replacement
Must not have
Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preop, 6 week, 1,2,3,4,5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the rate of hip dislocation in patients who had a hip replacement with the Restoration ADM X3 Acetabular System to rates in the literature for other primary hip systems.

Who is the study for?
This trial is for adults aged 18-75 with non-inflammatory degenerative joint disease needing a primary hip replacement. Candidates must be able to follow the study's procedures and not have systemic diseases, severe allergies to device materials, obesity (BMI ≥ 40), infections in the hip, excessive steroid use, prior hip replacements or fusions on the affected joint, or neuromuscular deficiencies.
What is being tested?
The study tests how well a new type of cementless hip replacement device called Restoration ADM X3 works by checking if it prevents dislocation of the femoral head within ten years after surgery compared to other devices documented in medical literature.
What are the potential side effects?
While specific side effects are not listed for this device trial, common risks associated with similar hip replacement surgeries include pain at the site, infection risk, possible dislocation or loosening of components over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of arthritis that is not caused by inflammation.
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I am eligible for a hip socket replacement without cement.
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I am between 18 and 75 years old, not pregnant, and 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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I have a condition like Lupus or Paget's disease affecting my bones.
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I am on long-term steroids or have a weakened immune system.
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I need surgery to fix or replace my previous hip implant.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Success Rate
Secondary study objectives
EQ-5D Index Score improvement from preoperative score
Harris Hip Score (HHS) score improvement from preoperative score
Lower Extremity Activity Scale (LEAS) improvement from preoperative score
+3 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: Restoration ADM X3 DeviceExperimental Treatment1 Intervention
Restoration ADM X3 Device in total hip replacement.

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,083 Total Patients Enrolled
Amit Atrey, MDPrincipal InvestigatorUnity Health Toronto
3 Previous Clinical Trials
450 Total Patients Enrolled
Anthony Hedley, M.D.Principal InvestigatorArizona Institute for Bone & Joint Disorders

Media Library

Restoration ADM X3 Device (Joint Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT01420237 — N/A
Hip Replacement Research Study Groups: Restoration ADM X3 Device
Hip Replacement Clinical Trial 2023: Restoration ADM X3 Device Highlights & Side Effects. Trial Name: NCT01420237 — N/A
Restoration ADM X3 Device (Joint Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01420237 — N/A
~35 spots leftby Jun 2026
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