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

University of Aarhus

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: P.F.C. Sigma knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01150929

20050031

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Fixed bearing

Active Comparator group

Description:

One of the 2 used implants.

Treatment:

Device: P.F.C. Sigma knee arthroplasty

Rotating platform

Active Comparator group

Description:

One of the 2 used implants.

Treatment:

Device: P.F.C. Sigma knee arthroplasty