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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00954954
First received: August 5, 2009
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: October 2006
Study Completion Date: July 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: P.F.C Sigma Rotating Platform Flex

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954954

Locations
Korea, Republic of
Seoul National University Hospital Department of Orthopaedic Surgery
Seoul, 28, Yongeon-Dong, Jongno-Gu, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Myung Chul Lee, MD, PhD Seoul National University Hospital Department of Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: Myung Chul Lee / Professor, Seoul National University Hospital Department of Orthopaedic Surgery
ClinicalTrials.gov Identifier: NCT00954954     History of Changes
Other Study ID Numbers: SNUHOSKNEE01-RPRPF
Study First Received: August 5, 2009
Last Updated: August 6, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Arthroplasty
Replacement
Knee
Range of Motion

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014