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

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Procedure: Total Knee Arthroplasty (TKA)

• Registration Number: NCT00899041
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Status Verified: 2011-12
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage):

• Primary due to osteo-arthritis
• Secondary due to rheumatoid arthritis or trauma

Exclusion Criteria

• Patients suffering from juvenile rheuma
• Patients suffering from hemophilia
• Patients that are incapable to give informed consent
• Patients who receive a total knee replacement due to an oncological resection
• Patients who have received a total knee replacement on the contralateral leg
• Patients who have disabling gonarthrosis on both legs
• Patients having a BMI < 25 kg/m^2
• Patients who have to receive a different prosthesis than used in this study for biomechanical reasons (e.g. revision prosthesis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard knee prosthesis	Total Knee Arthroplasty (TKA)	'standard' knee prosthesis (Sigma FB, J\&J, UK).
High flexion knee prosthesis	Total Knee Arthroplasty (TKA)	'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK).

Primary Outcome Measures

Name	Time	Method
Thigh-calf contact force	pre-op and 1-year post-op

Secondary Outcome Measures

Name	Time	Method
BMI, weight and length	pre-op and 1-year post-op
Passive/active maximal knee flexion angle	pre-op and 1-year post-op
Thigh and calf circumference	pre-op and 1-year post-op
IKS, WOMAC and VAS (pain/satisfaction) score	pre-op and 1-year post-op

Trial Locations

Locations (1)

Canisius-Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands