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

NCT ID: NCT01010828

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-01

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tri-Vector Approach

Group Type ACTIVE_COMPARATOR

Incision technique

Intervention Type PROCEDURE

Tri-Vector Approach retains the majority of 3 vectors of quadriceps.

Mini Mid-Vastus Approach

Group Type EXPERIMENTAL

Incision technique

Intervention Type PROCEDURE

Mini Mid-Vastus Approach

Interventions

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Incision technique

Tri-Vector Approach retains the majority of 3 vectors of quadriceps.

Intervention Type PROCEDURE

Incision technique

Mini Mid-Vastus Approach

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet Japan, Inc.

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Takashi Miyamoto, MD

Role: PRINCIPAL_INVESTIGATOR

Osaka Medical Center

Locations

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National Hospital Organization, Osaka National Hospital

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JP12

Identifier Type: -

Identifier Source: org_study_id

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