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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954954
Enrollment
170
Registered
2009-08-07
Start date
2006-10-31
Completion date
2009-07-31
Last updated
2009-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Arthroplasty, Replacement, Knee, Range of Motion

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.

Interventions

DEVICEStandard PS RP-MB (P.F.C Sigma Rotating Platform knee)

Comparison of different types of knee prosthesis

DEVICEHigh-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)

Comparison of different types of knee prosthesis

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026