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OpenTrials
Completed

NCT Number: NCT01010828

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

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.

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Key information

Conditions

Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital Organization, Osaka National Hospital

Osaka, 540-0006, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Incision technique

Procedure

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

Primary outcomes

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

    Time frame: intraoperatively

Secondary outcomes

  1. Incision length

    Time frame: intraoperatively

  2. Visual determination of the extension and flexion gap

    Time frame: intraoperatively

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Biomet Japan, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2009
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.