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

Radboud University Medical Center

Status: Completed

Conditions: Arthroplasty, Replacement, Knee

Treatments: Procedure: Total Knee Arthroplasty (TKA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00899041

ORL-FK-08/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

67 participants in 2 patient groups

Standard knee prosthesis

Active Comparator group

Description:

'standard' knee prosthesis (Sigma FB, J\&J, UK).

Treatment:

Procedure: Total Knee Arthroplasty (TKA)

High flexion knee prosthesis

Active Comparator group

Description:

'high flexion' knee prosthesis (Sigma RP-F, J\&J, UK).

Treatment:

Procedure: Total Knee Arthroplasty (TKA)