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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
Sponsor:
Collaborators:
Regionshospitalet Silkeborg
Gigtforeningen
Protesekompagniet
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01150929
First received: June 14, 2010
Last updated: February 18, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Osteoarthritis
 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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01150929

Contacts
Contact: Michael Tjornild, MD +4520743410 michtjoe@rm.dk
Contact: OrthoResearch Aarhus THG +89497202 ortoforsk@ki.au.dk

Locations
Denmark
Silkeborg Regional Hospital Recruiting
Silkeborg, Denmark, 8600
Contact: Betina M Nielsen, Study nurse     +4587222739     silkeborg.ko-projekt@rm.dk    
Contact: Helle M Hahn, Secretary     +4587222473     hellhahn@rm.dk    
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
Gigtforeningen
Protesekompagniet
Investigators
Study Chair: Kjeld Soballe, DMsc Aarhus Sygehus THG
  More Information

Additional Information:
Orthopedic Research Aarhus, Denmark  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michael Tjornild/MD, PhD-student, Regionshospitalet Silkeborg
ClinicalTrials.gov 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
RSA
DXA
Gait analysis
Motion analysis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013