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Completed

NCT Number: NCT00954954

Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty

The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital Department of Orthopaedic Surgery

Seoul, 28, Yongeon-Dong, Jongno-Gu, 110-744, South Korea

About this study

A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A diagnosis of primary osteoarthritis of knee
  • A candidate for total knee replacement arthroplasty

Exclusion criteria

  • A diagnosis other than primary osteoarthritis
  • A history of previous open knee surgery

Treatment and study plan

Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)

Device

Comparison of different types of knee prosthesis

Other names: P.F.C Sigma Rotating Platform knee

High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Device

Comparison of different types of knee prosthesis

Other names: P.F.C Sigma Rotating Platform Flex

Primary outcomes

  1. Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.

    Time frame: 2 years

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Aug 7, 2009
Registry last updated
Aug 7, 2009

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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