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Completed

NCT Number: NCT01102829

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, 2300RC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. Muscle activity

    Time frame: 6 months post-operatively

    Bipolar surface EMG data of the flexor and extensor muscles is collected.

  4. 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.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: ROCC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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