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Dual Mobility System

Primary Total Hip Arthroplasty (THA) for Hip Revision Surgery (OR3O Trial)

N/A
Recruiting
Led By Ran Schwarzkopf, MD
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 1 year, 2 years, 5 years, and 10 years
Awards & highlights

Summary

The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.

Eligible Conditions
  • Hip Revision Surgery
  • Hip Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 1 year, 2 years, 5 years, and 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 1 year, 2 years, 5 years, and 10 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
Survivorship of Primary Total Hip Arthroplasty (THA)
Secondary outcome measures
Five-level EuroQol five-dimensional (EQ-5D-5L) score
Forgotten Joint Score 12 (FJS-12)
Harris Hip Score (HHS)
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Revision Total Hip Arthroplasty (THA)Experimental Treatment1 Intervention
OR3O Dual Mobility System used in revision THA
Group II: Primary Total Hip Arthroplasty (THA)Experimental Treatment1 Intervention
OR3O Dual Mobility System used in primary THA

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Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
167 Previous Clinical Trials
21,931 Total Patients Enrolled
Ran Schwarzkopf, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
2,490 Total Patients Enrolled
~62 spots leftby Dec 2026
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