299 Participants Needed

A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis

Recruiting at 21 trial locations
RB
ET
AC
AW
Overseen ByAlison Walker
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Smith & Nephew, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AK

Amir Kamali

Principal Investigator

Smith & Nephew, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
OR Preoperative KOOS JR and radiographs have been obtained
6-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-Surgery Assessment

X-rays and questionnaires are administered to assess knee pain, activities of daily living, quality of life, and patient feelings about their knee

1-2 weeks
1 visit (in-person)

Surgery and Immediate Post-Operative Care

Patients undergo total knee replacement surgery with the Smith and Nephew Porous Total Knee System

1 week
Hospital stay for surgery and recovery

Post-Operative Follow-up

Participants are monitored for safety and effectiveness, including radiographic assessments and patient-reported outcomes

5 years
Regular visits at 6 weeks, 6 months, 1 year, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Porous Total Knee System
How Is the Trial Designed?
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)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials
176
Recruited
23,500+
Dr. Maria Berkman profile image

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath profile image

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

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