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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014