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Completed

NCT Number: NCT01150929

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P.F.C. Sigma knee arthroplasty

Device

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

Other names: PFC Sigma from DePuy International implants used.

Primary outcomes

  1. Radio Stereometric Analysis

    Time frame: 24 months

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

Secondary outcomes

  1. Gait analysis

    Time frame: 12 months

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

  2. DXA

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Gigtforeningen
  • Protesekompagniet
  • Regionshospitalet Silkeborg

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
Jun 25, 2010
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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