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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00899041
Collaborator
Johnson & Johnson Medical BV, The Netherlands (Other), Canisius-Wilhelmina Hospital (Other)
67
Enrollment
1
Location
2
Arms
60
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total Knee Arthroplasty (TKA)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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)
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Thigh-calf contact force [pre-op and 1-year post-op]

    Secondary Outcome Measures

    1. Passive/active maximal knee flexion angle [pre-op and 1-year post-op]

    2. BMI, weight and length [pre-op and 1-year post-op]

    3. Thigh and calf circumference [pre-op and 1-year post-op]

    4. IKS, WOMAC and VAS (pain/satisfaction) score [pre-op and 1-year post-op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Canisius-Wilhelmina Hospital Nijmegen Netherlands 6532 SZ

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Johnson & Johnson Medical BV, The Netherlands
    • Canisius-Wilhelmina Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00899041
    Other Study ID Numbers:
    • ORL-FK-08/02
    First Posted:
    May 12, 2009
    Last Update Posted:
    Nov 8, 2013
    Last Verified:
    Dec 1, 2011
    Keywords provided by Radboud University Medical Center
    Prosthesis

    Study Results

    No Results Posted as of Nov 8, 2013