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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00899041

Enrollment

Registered

2009-05-12

Start date

2008-10-31

Completion date

2013-10-31

Last updated

2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee

Keywords

Prosthesis

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.

Interventions

PROCEDURETotal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

Measure	Time frame
Thigh-calf contact force	pre-op and 1-year post-op

Secondary

Measure	Time frame
Passive/active maximal knee flexion angle	pre-op and 1-year post-op
BMI, weight and length	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026