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Orthopedic Implant

Acetabular Shell Revision for Hip Arthritis (RAS Trial)

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the success of hip replacement from previously failed total hip replacements in consecutive patients who meet the criteria.

Who is the study for?
This trial is for individuals needing a revision of a failed hip replacement component, specifically with the Restoration Anatomic Acetabular Shell. Participants must be adults who can follow post-op check-ups and have signed an informed consent form. Those with extreme obesity (BMI > 45), infections around the hip, immune suppression, mental or neuromuscular issues affecting recovery, poor bone quality, or sensitivity to device materials cannot join.
What is being tested?
The study is testing the long-term effectiveness ('survivorship') of the RAS acetabular shell in patients whose previous total hip arthroplasty has failed. It's a non-randomized study tracking patients both retrospectively and prospectively after they receive this specific implant.
What are the potential side effects?
While not explicitly listed in your information provided, typical side effects from similar procedures may include pain at the implant site, infection risks, possible dislocation or instability of the new component, allergic reactions to material if present before exclusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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
Adverse Events

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 Anatomic Acetabular ShellExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,379 Total Patients Enrolled

Media Library

Restoration Anatomic Acetabular Shell (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05591859 — N/A
Hip Arthritis Research Study Groups: Restoration Anatomic Acetabular Shell
Hip Arthritis Clinical Trial 2023: Restoration Anatomic Acetabular Shell Highlights & Side Effects. Trial Name: NCT05591859 — N/A
Restoration Anatomic Acetabular Shell (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591859 — N/A
~37 spots leftby Mar 2036
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