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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954954
• Other study ID #: SNUHOSKNEE01-RPRPF
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2009
• Last updated: August 6, 2009
• Start date: October 2006
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
Comparison of different types of knee prosthesis
• High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)
Comparison of different types of knee prosthesis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Department of Orthopaedic Surgery	Seoul	28, Yongeon-Dong, Jongno-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.		2 years	No