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

This study has been completed.
Sponsor:
Collaborators:
Johnson & Johnson Medical BV, The Netherlands
Canisius-Wilhelmina Hospital
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00899041
First received: May 11, 2009
Last updated: November 7, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Knee
Procedure: Total Knee Arthroplasty (TKA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Thigh-calf contact force [ Time Frame: pre-op and 1-year post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Passive/active maximal knee flexion angle [ Time Frame: pre-op and 1-year post-op ] [ Designated as safety issue: No ]
  • BMI, weight and length [ Time Frame: pre-op and 1-year post-op ] [ Designated as safety issue: No ]
  • Thigh and calf circumference [ Time Frame: pre-op and 1-year post-op ] [ Designated as safety issue: No ]
  • IKS, WOMAC and VAS (pain/satisfaction) score [ Time Frame: pre-op and 1-year post-op ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: October 2008
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899041

Locations
Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands, 6532 SZ
Sponsors and Collaborators
Radboud University
Johnson & Johnson Medical BV, The Netherlands
Canisius-Wilhelmina Hospital
Investigators
Principal Investigator: Nico Verdonschot, Prof. Radboud University
  More Information

Publications:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00899041     History of Changes
Other Study ID Numbers: ORL-FK-08/02
Study First Received: May 11, 2009
Last Updated: November 7, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Prosthesis

ClinicalTrials.gov processed this record on April 22, 2014