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

University of Aarhus55 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Osteoarthritis

Interventions

P.F.C. Sigma knee arthroplastyDEVICE

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Silkeborg Regional Hospital

Silkeborg, Denmark

Outcomes

Primary Outcomes

Radio Stereometric Analysis

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

Time frame: 24 months

Secondary Outcomes

Gait analysis

Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control.

Time frame: 12 months

DXA

Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant.

Time frame: 24 months

Data from ClinicalTrials.gov

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