Comparison of Nonposterior- and Posterior-Stabilized Mobi... | NCT01075620

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

NCT01075620

Sponsor

Ewha Womans University

Status

Completed

Last Update Posted

Feb 25, 2010Estimated

Enrollment

126Actual

Phase

Phase 4

Conditions

Osteoarthritis

Interventions

PFC-Sigma RP
LPS RP

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Dec 2002Actual

Completion Date

Jan 2010Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 24, 2010

First Posted Date

Feb 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2010

Last Update Posted Date

Feb 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.
whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
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
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PFC sigma RP	Experimental	Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana)	Device: PFC-Sigma RP
LCS RP	Active Comparator	non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana	Device: LPS RP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PFC-Sigma RP	Device	Posterior stabilizing rotating platform total knee components	PFC sigma RP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Society knee score		at 3 months, 1 year, than annually

Secondary Outcomes

Measure	Description	Time Frame
Range of motion		at 3 months, 1 year, than annually

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoowang Choi, MD	Ewha Womans University Mokdong Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ewha Womans University Mokdong Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided