Comparing Fixed-bearing Versus Mobile-bearing Prosthesis... | NCT01312532

Studies
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial

NCT01312532

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Mar 10, 2011Estimated

Enrollment

100Actual

Phase

Phase 2

Conditions

Osteoarthritis

Interventions

fixed-bearing (P.F.C.® Sigma)
mobile-bearing (P.F.C.® Sigma)

Countries

Iran

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

Jun 2004

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

Jun 2004

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Mar 9, 2011

First Submission Date that Met QC Criteria

Mar 9, 2011

First Posted Date

Mar 10, 2011Estimated

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

Mar 9, 2011

Last Update Posted Date

Mar 10, 2011Estimated

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 which prosthesis is better in total knee arthroplasty

Detailed Description

Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fixed-bearing	Other	fixed-bearing device is a kind of prosthesis	Device: fixed-bearing (P.F.C.® Sigma)
mobile-bearing	Other	mobile-bearing device is a kind of prosthesis	Device: mobile-bearing (P.F.C.® Sigma)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fixed-bearing (P.F.C.® Sigma)	Device	P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK	fixed-bearing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Knee Society Scoring	was used for evaluating the function of the knee and high scores indicated better knee function	five years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Pain	Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain).	five years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with expected primary total knee arthroplasty

Exclusion Criteria:

Mediolateral instability
Infective arthritis
Severe deformity
Revision

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohammad dehghani, A.Professor	Isfahan University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-zahra university hospital		Isfahan	Isfahan		Iran

Label	URL
Isfahan university of medical sciences	View source

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