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Prosthetic Implant

LEGION Porous CR without Hydroxyapatite for Osteoarthritis

N/A
Waitlist Available
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 1 year, 2 years and 5 years
Awards & highlights

Summary

A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.

Eligible Conditions
  • Osteoarthritis
  • Arthritis
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years and 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
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Secondary study objectives
Implant Survival Rate Up to 5 Years Post-Operation
Patient Reported Outcomes - Forgotten Joint Score (FJS)
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: LEGION Porous CR without HydroxyapatiteExperimental Treatment1 Intervention
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects)
Group II: LEGION Porous CR with HydroxyapatiteExperimental Treatment1 Intervention
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Arthroplasty
2017
Completed Phase 4
~1820

Find a Location

Who is running the clinical trial?

Smith & Nephew, Inc.Lead Sponsor
167 Previous Clinical Trials
21,809 Total Patients Enrolled
32 Trials studying Osteoarthritis
4,336 Patients Enrolled for Osteoarthritis
Amir KamaliStudy DirectorSmith & Nephew, Inc.
~93 spots leftby Dec 2025
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