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Clinical Trials/NCT01102829
NCT01102829
Completed
N/A

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

Leiden University Medical Center1 site in 1 country11 target enrollmentSeptember 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Leiden University Medical Center
Enrollment
11
Locations
1
Primary Endpoint
Migration
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
April 2010
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Leiden University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Migration

Time Frame: 24 months post-operatively

Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.

Secondary Outcomes

  • anterior-posterior translation patterns(6 months post-operatively)
  • Axial rotation patterns(6 months post-operatively)
  • Muscle activity(6 months post-operatively)
  • Shear forces(6 months post-operatively)

Study Sites (1)

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