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CompletedNCT01102829ROCCUpdated Apr 13, 2010

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

An observational study in Rheumatoid Arthritis, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2010-04-13.

Sponsored by Leiden University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11
Sex
All
01

Study 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).

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Knee Joint
  • Arthroplasty
  • Replacement
  • Knee
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 11 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary care clinic

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11 participants (actual)
06

What researchers measure

Primary outcomes

  1. Migration

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

    Time frame: 24 months post-operatively

Secondary outcomes

  1. anterior-posterior translation patterns

    Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.

    Time frame: 6 months post-operatively

  2. Axial rotation patterns

    Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component

    Time frame: 6 months post-operatively

  3. Muscle activity

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

    Time frame: 6 months post-operatively

  4. Shear forces

    A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.

    Time frame: 6 months post-operatively

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Study locations

1 site
  • Leiden University Medical Center
    Leiden, 2300RC, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01102829
Lead sponsor
Leiden University Medical Center
First posted
Apr 13, 2010
Start date
Sep 2007
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Apr 13, 2010

Study contacts

Rob GH Nelissen, Prof, MD
principal investigator · Leiden University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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