NCT00899041

Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements

In-vivo Study Investigating the Difference in Functional Outcome Between Two Types of Knee Prostheses: the Sigma FB (Depuy, J&J, UK; Standard Implant) and the Sigma RP-F (Depuy, J&J, UK; High-flexion Implant)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.

Detailed description

Study title: Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements. Objective: The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J\&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J\&J, UK). Study Design: Prospective double blind randomized study. Study population: Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma. Intervention: * 28 subjects will receive the standard Sigma FB knee prosthesis. * 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
PROCEDURE	Total Knee Arthroplasty (TKA)	28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2009-05-12
• Last updated: 2013-11-08

Locations

1 site across 1 country: Netherlands