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

March 25, 2019 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan, 540-0006
        • National Hospital Organization, Osaka National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tri-Vector Approach
Procedure: Incision technique
Tri-Vector Approach retains the majority of 3 vectors of quadriceps.
Procedure: Incision technique
Mini Mid-Vastus Approach
EXPERIMENTAL: Mini Mid-Vastus Approach
Procedure: Incision technique
Tri-Vector Approach retains the majority of 3 vectors of quadriceps.
Procedure: Incision technique
Mini Mid-Vastus Approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Biomet Japan, Inc.

Investigators

  • Principal Investigator: Takashi Miyamoto, MD, Osaka Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2009

Primary Completion (ACTUAL)

March 31, 2012

Study Completion (ACTUAL)

March 31, 2012

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JP12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Clinical Trials on Incision technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe