NCT02139345

TC-A Registration Study

A Prospective, Randomized, Multicenter Clinical Study to Compare the Safety and Efficacy of TC-A PS Total Knee System With TC-PLUS Solution PS Total Knee System in Chinese Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Smith & Nephew Medical (Shanghai) Ltd · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multicenter clinical study to compare the safety and efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese subjects.

Detailed description

Osteoarthritis (OA), also known as degenerative joint disease or hyperostosis, is the most common cause of knee arthritis. Pain, dyskinesia and disability induced by osteoarthritis impact severely on the subject's health and quality of life. Knee osteoarthritis is very common in the elderly population. As life expectancy has increased, the incidence of osteoarthritis rose significantly during the 20th century. For people over 60 years of age, approximately 50% show signs of osteoarthritis on x-rays, among which 35% -50% show clinical signs. For people over the age of 75, 80% had osteoarthritis symptoms. There has been an increase in imported knee prostheses during the past decade, so that surgeons now have more choices of implants. However, the high cost of imported prostheses has become a barrier to the development of TKA in China and caused many OA subjects requiring immediate TKA to have to delay or miss their surgery. The development and promotion of high-quality domestic joint implants and surgical instruments is the key to the development of TKA technique in China. The primary objective of this study is to demonstrate non-inferiority of subjects implanted with the TC-A PS total knee system compared to a randomized concurrent control group of subjects implanted with the TC-PLUS Solution PS total knee system in terms of Knee Society Clinical Score (KSCS) at 1 year.

Conditions

• Primary Osteoarthritis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Avascular Necrosis

Interventions

Type	Name	Description
DEVICE	TC-A PS Total Knee Replacement System	Subject will be implanted with the TC-A PS Total Knee Replacement System
DEVICE	TC-PLUS Solution PS Total Knee Replacement System	Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System

Timeline

• Start date: 2014-09-23
• Primary completion: 2016-11-23
• Completion: 2016-11-23
• First posted: 2014-05-15
• Last updated: 2017-11-14

Locations

4 sites across 1 country: China