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Joint Replacement

Restoration ADM X3 Device for Hip Replacement

N/A
Waitlist Available
Led By Ajay Aggarwal, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preop, 6 week, 1,2,3,4,5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Success Rate
Secondary outcome measures
All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System
Complication rates for Psoas Impingement and Associated Groin Pain
EQ-5D Index Score improvement from preoperative score
+6 more

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
77 Previous Clinical Trials
19,881 Total Patients Enrolled
Ajay Aggarwal, MDPrincipal InvestigatorMissouri Orthopaedic Institute
1 Previous Clinical Trials
Brian C de Beaubien, M.D.Principal InvestigatorCovenant Medical Center

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

Frequently Asked Questions

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

Is my eligibility established for participation in this experiment?

"Aspiring participants in this research must have undergone arthroplasty and be between 18-75 years of age. 352 people will ultimately comprise the study's sample size."

Answered by AI

Is there still an opportunity to join this clinical trial as a participant?

"This study, which was published on June 1st 2011 and last updated on August 26th 2022, is no longer accepting patients. However, there are twenty-six alternate trials that currently require volunteers."

Answered by AI

Is there an age limit to be eligible for this research project?

"This clinical trial only considers patients aged 18-75. Separate studies are available for those under 18 and above 65, of which there are a total of 28."

Answered by AI

How many healthcare facilities are currently conducting this clinical trial?

"Currently, 11 sites are open to enrolling participants for this medical trial. Notable locations include OrthoArizona in Gilbert, St. Cloud Orthopedic Associates in Sartell and Tucson Orthopaedic Institute in Tucson among several others."

Answered by AI
~51 spots leftby Jun 2026