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

November 7, 2013 updated by: Radboud University Medical Center

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard knee prosthesis
'standard' knee prosthesis (Sigma FB, J&J, UK).
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.
Other Names:
  • Sigma RP-F, J&J, UK
  • Sigma FB, J&J, UK
ACTIVE_COMPARATOR: High flexion knee prosthesis
'high flexion' knee prosthesis (Sigma RP-F, J&J, UK).
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.
Other Names:
  • Sigma RP-F, J&J, UK
  • Sigma FB, J&J, UK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thigh-calf contact force
Time Frame: pre-op and 1-year post-op
pre-op and 1-year post-op

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Canisius-Wilhelmina Hospital
Johnson & Johnson Medical BV, The Netherlands

Investigators

  • Principal Investigator: Nico Verdonschot, Prof., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORL-FK-08/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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