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

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: 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)

• Registration Number: NCT00954954
• Lead Sponsor: Seoul National University Hospital

Brief 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.

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 Timeline

• Study Start: 2006-10
• Primary Completion: 2007-06
• Study Completion: 2009-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-06
• Last Update Submitted: 2009-08-06
• Study First Posted: 2009-08-07
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)	Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses
High-flexion	High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)	Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses

Primary Outcome Measures

Name	Time	Method
Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.	2 years

Trial Locations

Locations (1)

Seoul National University Hospital Department of Orthopaedic Surgery; 🇰🇷 Seoul, 28, Yongeon-Dong, Jongno-Gu, Korea, Republic of