Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design (ROCC)

April 12, 2010 updated by: Leiden University Medical Center

Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA

The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

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
      • Leiden, Netherlands, 2300RC
        • Leiden University Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
  • Patient is capable of giving informed consent and expressing a willingness to comply with this study
  • Patient has no major deformities
  • The ability to perform a lunge and step-up motion without the help of bars or a cane.
  • No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)

Exclusion Criteria:

  • The patient is unable or unwilling to sign the Informed Consent specific to this study
  • The individual has a functional impairment of any other lower extremity joint besides the operated knee
  • Patient has a flexion contracture of more than 15°
  • Patient has a varus/valgus contracture of more than 15°
  • Patients requiring revision arthroplasty
  • The patient does not understand the Dutch or English language good enough to participate.
  • The use of walking aids
  • The inability to walk more than 500 meters

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migration
Time Frame: 24 months post-operatively
Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.
24 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anterior-posterior translation patterns
Time Frame: 6 months post-operatively
Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.
6 months post-operatively
Axial rotation patterns
Time Frame: 6 months post-operatively
Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component
6 months post-operatively
Muscle activity
Time Frame: 6 months post-operatively
Bipolar surface EMG data of the flexor and extensor muscles is collected.
6 months post-operatively
Shear forces
Time Frame: 6 months post-operatively
A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.
6 months post-operatively

Collaborators and Investigators

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

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Rob GH Nelissen, Prof, MD, Leiden University Medical Center

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

September 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 9, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROCC

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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