NCT02355652

Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

Comparison of Two Surgical Strategies of Total Knee Arthroplasty : Cemented Versus Uncemented HLS Knee-Tec Prosthesis System. A Prospective Randomized Study.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA). Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA. The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative. The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Surgical total knee replacement using cemented components	Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
DEVICE	Surgical total knee replacement using uncemented components	Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2015-02-04
• Last updated: 2017-01-06

Locations

1 site across 1 country: France