Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 25, 2014