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

NCT ID: NCT01150929

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-01

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Knee arthroplasty RSA DXA Gait analysis Motion analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Fixed bearing

One of the 2 used implants.

Group Type ACTIVE_COMPARATOR

P.F.C. Sigma knee arthroplasty

Intervention Type DEVICE

Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene

Rotating platform

One of the 2 used implants.

Group Type ACTIVE_COMPARATOR

P.F.C. Sigma knee arthroplasty

Intervention Type DEVICE

Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene

Interventions

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P.F.C. Sigma knee arthroplasty

Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene

Intervention Type DEVICE

Other Intervention Names

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PFC Sigma from DePuy International implants used.

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Silkeborg

OTHER

Sponsor Role collaborator

Gigtforeningen

OTHER

Sponsor Role collaborator

Protesekompagniet

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjeld Soballe, DMsc

Role: STUDY_CHAIR

Aarhus Sygehus THG

Locations

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Silkeborg Regional Hospital

Silkeborg, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://www.orthoresearch.dk

Orthopedic Research Aarhus, Denmark

Other Identifiers

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20050031

Identifier Type: -

Identifier Source: org_study_id