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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01150929

Enrollment

Registered

2010-06-25

Start date

2007-03-01

Completion date

2014-12-31

Last updated

2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis

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.

Interventions

DEVICEP.F.C. Sigma knee arthroplasty

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026