NCT03059927

The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Lovisenberg Diakonale Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gonarthrosis; Primary
• Degenerative Joint Disease of Knee

Interventions

Type	Name	Description
PROCEDURE	Knee arthroplasty, Cruciate retaining	Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design
PROCEDURE	Knee arthroplasty, Anterior stabilized	Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design
PROCEDURE	Knee arthroplasty, Posterior stabilized	Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design

Timeline

• Start date: 2017-03-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2017-02-23
• Last updated: 2017-04-20

Locations

2 sites across 1 country: Norway