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Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01075620
Enrollment
126
Registered
2010-02-25
Start date
2002-05-31
Completion date
2010-01-31
Last updated
2010-02-25

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

Conditions

Osteoarthritis

Keywords

rotating platform, posterior stabilized, non-posterior stabilized

Brief summary

The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Detailed description

Out comes measures were to determine 1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis. 2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis. 3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis 4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Interventions

DEVICEPFC-Sigma RP

Posterior stabilizing rotating platform total knee components

DEVICELPS RP

non-posterior stabilized rotating platform design

Sponsors

Ewha Womans University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion criteria

* Inflammatory disease * patient with other Lower extremity disease which may affect functional outcome * Neurologic disease effecting patients lower extremity * Revision surgery * Patient not medically cleared for bilateral surgery

Design outcomes

Primary

MeasureTime frame
Knee Society knee scoreat 3 months, 1 year, than annually

Secondary

MeasureTime frame
Range of motionat 3 months, 1 year, than annually

Countries

South Korea

Outcome results

None listed

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