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

Not Applicable

Completed

• Conditions: Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

• Registration Number: NCT01010828
• Lead Sponsor: Zimmer Biomet

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 available

Study Timeline

• Study Start: 2009-10-01
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2012-03-31
• Study Completion: 2012-03-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Force from femoral and tibial side to retract and bring visual field into view	intraoperatively

Secondary Outcome Measures

Name	Time	Method
Incision length	intraoperatively
Visual determination of the extension and flexion gap	intraoperatively

Trial Locations

Locations (1)

National Hospital Organization, Osaka National Hospital; 🇯🇵 Osaka, Japan