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

NCT00899041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2013-11-08

No results posted yet for this study

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.

Conditions

  • Arthroplasty, Replacement, Knee

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Medical BV, The Netherlands

    collaborator UNKNOWN
  • Canisius-Wilhelmina Hospital

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Nico Verdonschot, Prof. · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00899041 on ClinicalTrials.gov