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

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

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.

Published trials that share one or more normalized conditions with this study.

Completed