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

Primary Purpose

Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Incision technique

About this trial

This is an interventional treatment trial for Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

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.)

Sites / Locations

National Hospital Organization, Osaka National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tri-Vector Approach

Mini Mid-Vastus Approach

Arm Description

Outcomes

Primary Outcome Measures

Force from femoral and tibial side to retract and bring visual field into view

Secondary Outcome Measures

Incision length

Visual determination of the extension and flexion gap

Full Information

NCT ID

NCT01010828

First Posted

November 9, 2009

Last Updated

March 25, 2019

Sponsor

Zimmer Biomet

Collaborators

Biomet Japan, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01010828

Brief Title

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

Official Title

Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2009 (Actual)

Primary Completion Date

March 31, 2012 (Actual)

Study Completion Date

March 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

Collaborators

Biomet Japan, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tri-Vector Approach

Arm Type

Active Comparator

Arm Title

Mini Mid-Vastus Approach

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Incision technique

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Incision technique

Intervention Description

Mini Mid-Vastus Approach

Primary Outcome Measure Information:

Title

Force from femoral and tibial side to retract and bring visual field into view

Time Frame

intraoperatively

Secondary Outcome Measure Information:

Title

Incision length

Time Frame

intraoperatively

Title

Visual determination of the extension and flexion gap

Time Frame

intraoperatively

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takashi Miyamoto, MD

Organizational Affiliation

Osaka Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Hospital Organization, Osaka National Hospital

City

Osaka

ZIP/Postal Code

540-0006

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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