Comparison of the Tibiofemoral Rotational Alignment After... | NCT01751334

Studies
Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

NCT01751334

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 18, 2012Estimated

Enrollment

80Actual

Phase

Phase 4

Conditions

Osteoarthritis

Interventions

total knee arthroplasty
total knee arthroplasty

Countries

Not provided

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

Dec 2012

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

Sep 2005

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 18, 2012Estimated

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

Dec 13, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

Detailed Description

Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mobile Bearing	Experimental	Mobile bearing total knee arthroplasty	Device: total knee arthroplasty
Fixed Bearing	Active Comparator	Fixed Bearing total knee arthroplasty	Device: total knee arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
total knee arthroplasty	Device	Mobile Bearing Total knee Arthroplasty	Mobile Bearing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tibial anteroposterior axis relative to femoral anteroposterior axis	Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images	postoperative 2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary osteoarthritis

Exclusion Criteria:

infection
inflammatory arthritis
reoperation
severe deformity

Accepts Healthy Volunteers

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
Sahnghoon Lee, M.D., Ph.D.		Principal Investigator
Myung Chul Lee, M.D., Ph.D.		Study Chair

Locations

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided