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

Study Overview
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: P.F.C. Sigma knee arthroplasty


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed bearing<br>One of the 2 used implants. | Device: P.F.C. Sigma knee arthroplasty<br>* Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene<br>* Other names: PFC Sigma from DePuy International implants used.;|
| Active Comparator: Rotating platform<br>One of the 2 used implants. | Device: P.F.C. Sigma knee arthroplasty<br>* Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene<br>* Other names: PFC Sigma from DePuy International implants used.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radio Stereometric Analysis | Patients are analysed with stereo x-rays to asses implant micromigration. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait analysis | Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control. | 12 months | 
| DXA | Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis