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Clinical Trials/NCT01150929
NCT01150929
Completed
N/A

Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene

University of Aarhus1 site in 1 country55 target enrollmentMarch 1, 2007
ConditionsOsteoarthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Aarhus
Enrollment
55
Locations
1
Primary Endpoint
Radio Stereometric Analysis
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2007
End Date
December 31, 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Radio Stereometric Analysis

Time Frame: 24 months

Patients are analysed with stereo x-rays to asses implant micromigration.

Secondary Outcomes

  • Gait analysis(12 months)
  • DXA(24 months)

Study Sites (1)

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