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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Device: P.F.C. Sigma knee arthroplasty

• Registration Number: NCT01150929
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2012-08-31
• Study Completion: 2014-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed bearing	P.F.C. Sigma knee arthroplasty	One of the 2 used implants.
Rotating platform	P.F.C. Sigma knee arthroplasty	One of the 2 used implants.

Primary Outcome Measures

Name	Time	Method
Radio Stereometric Analysis	24 months	Patients are analysed with stereo x-rays to asses implant micromigration.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Silkeborg Regional Hospital; 🇩🇰 Silkeborg, Denmark