Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Aarhus.
Recruitment status was  Recruiting
Regionshospitalet Silkeborg
Information provided by:
University of Aarhus Identifier:
First received: June 14, 2010
Last updated: February 18, 2011
Last verified: February 2011

The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.

The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.

Condition Intervention
Device: P.F.C. Sigma knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Radio Stereometric Analysis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients are analysed with stereo x-rays to asses implant micromigration.

Secondary Outcome Measures:
  • Gait analysis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control.

  • DXA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant.

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fixed bearing
One of the 2 used implants.
Device: P.F.C. Sigma knee arthroplasty
Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
Other Name: PFC Sigma from DePuy International implants used.
Active Comparator: Rotating platform
One of the 2 used implants.
Device: P.F.C. Sigma knee arthroplasty
Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
Other Name: PFC Sigma from DePuy International implants used.


Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.

Exclusion Criteria:

  • Neurologic disease with impact on gait.
  • Orthopaedic disease ipsilateral hip joint.
  • Patients outside the age limits.
  • No informed consent signed.
  • Patients suffering from dementia.
  • Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
  • Patients who later develop deep venous thrombosis or infection in the operated knee.
  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 identifier: NCT01150929

Contact: Michael Tjornild, MD +4520743410
Contact: OrthoResearch Aarhus THG +89497202

Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Betina M Nielsen, Study nurse    +4587222739   
Contact: Helle M Hahn, Secretary    +4587222473   
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
Study Chair: Kjeld Soballe, DMsc Aarhus Sygehus THG
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Tjornild/MD, PhD-student, Regionshospitalet Silkeborg Identifier: NCT01150929     History of Changes
Other Study ID Numbers: 20050031
Study First Received: June 14, 2010
Last Updated: February 18, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Knee arthroplasty
Gait analysis
Motion analysis processed this record on November 27, 2015