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

August 6, 2009 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • 28, Yongeon-Dong, Jongno-Gu
      • Seoul, 28, Yongeon-Dong, Jongno-Gu, Korea, Republic of, 110-744
        • Seoul National University Hospital Department of Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard
Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses
Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
Comparison of different types of knee prosthesis
Other Names:
  • P.F.C Sigma Rotating Platform knee
ACTIVE_COMPARATOR: High-flexion
Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses
Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
Comparison of different types of knee prosthesis
Other Names:
  • P.F.C Sigma Rotating Platform Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Myung Chul Lee, MD, PhD, Seoul National University Hospital Department of Orthopaedic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

August 5, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (ESTIMATE)

August 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2009

Last Update Submitted That Met QC Criteria

August 6, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUHOSKNEE01-RPRPF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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