The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Degenerative Joint Disease of Knee Clinical Trial

Official title: The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial

Status Recruiting

Clinical Trial Summary

The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Clinical Trial Description

Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants. ;

Related Conditions & MeSH terms

• Degenerative Joint Disease of Knee
• Gonarthrosis; Primary
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT03059927
• Study type: Interventional
• Source: Lovisenberg Diakonale Hospital
• Contact: Yasser Rehman, MD
• Phone: +4798477583
• Email: yare@lds.no
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Completion date: December 31, 2023