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Clinical Trials/NCT01150929
NCT01150929CompletedNot Applicable

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

University of Aarhus1 site in 1 country55 target enrollmentStarted: March 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
1
Primary Endpoint
Radio Stereometric Analysis
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
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.

Arms & Interventions

Fixed bearing

Active Comparator

One of the 2 used implants.

Intervention: P.F.C. Sigma knee arthroplasty (Device)

Rotating platform

Active Comparator

One of the 2 used implants.

Intervention: P.F.C. Sigma knee arthroplasty (Device)

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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