Review on Minimally Invasive Skin Incision in Vanguard PS... | NCT01010828

Studies
Review on Minimally Invasive Skin Incision in Vanguard PS Artificial Knee Joint System

NCT01010828

Sponsor

Zimmer Biomet

Status

Completed

Last Update Posted

Mar 27, 2019Actual

Enrollment

72Actual

Phase

Not Applicable

Conditions

Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Interventions

Incision technique
Incision technique

Countries

Japan

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

Mar 2019

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

Oct 1, 2009Actual

Primary Completion Date

Mar 31, 2012Actual

Completion Date

Mar 31, 2012Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 9, 2009

First Posted Date

Nov 10, 2009Estimated

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 25, 2019

Last Update Posted Date

Mar 27, 2019Actual

Name	Class
Biomet Japan, Inc.	INDUSTRY

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

This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tri-Vector Approach	Active Comparator		Procedure: Incision technique
Mini Mid-Vastus Approach	Experimental		Procedure: Incision technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Incision technique	Procedure	Tri-Vector Approach retains the majority of 3 vectors of quadriceps.	Tri-Vector Approach

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Force from femoral and tibial side to retract and bring visual field into view		intraoperatively

Secondary Outcomes

Measure	Description	Time Frame
Incision length		intraoperatively
Visual determination of the extension and flexion gap		intraoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.

Exclusion Criteria:

Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)

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
Takashi Miyamoto, MD	Osaka Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Hospital Organization, Osaka National Hospital		Osaka		540-0006	Japan