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

L

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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