NCT05197036

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

A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who need a total knee replacement or have recently had a total knee replacement with the Smith and Nephew Porous Total Knee System will be enrolled into the study. Before surgery X-rays will be collected and questionnaires will be administered which ask the patient about knee pain, activities of daily living, quality of life and how they feel about their knee. The same X-rays and questionnaires will be asked before surgery and then after surgery at various intervals up to 10 years post-surgery.

Conditions

• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	Total Knee Arthroplasty	A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.

Timeline

• Start date: 2021-12-21
• Primary completion: 2026-06-19
• Completion: 2033-12-25
• First posted: 2022-01-19
• Last updated: 2026-01-30

Locations

18 sites across 5 countries: United States, Australia, Canada, Netherlands, Sweden