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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014