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

This study has been completed.
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01102829
First received: April 9, 2010
Last updated: April 12, 2010
Last verified: April 2010
History of Changes
  Purpose

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).


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Migration [ Time Frame: 24 months post-operatively ] [ Designated as safety issue: No ]
    Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.


Secondary Outcome Measures:
  • anterior-posterior translation patterns [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.

  • Axial rotation patterns [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component

  • Muscle activity [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    Bipolar surface EMG data of the flexor and extensor muscles is collected.

  • Shear forces [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
    A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.


Enrollment: 11
Study Start Date: September 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102829

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300RC
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: Rob GH Nelissen, Prof, MD Leiden University Medical Center
  More Information

No publications provided

Responsible Party: N. Wolterbeek, MSc (principal investigator), Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01102829     History of Changes
Other Study ID Numbers: ROCC
Study First Received: April 9, 2010
Last Updated: April 12, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Leiden University Medical Center:
Knee Joint
Arthroplasty
Replacement
Knee

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013