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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01010828
Enrollment
72
Registered
2009-11-10
Start date
2009-10-01
Completion date
2012-03-31
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

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.

Interventions

PROCEDUREIncision technique

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

Sponsors

Biomet Japan, Inc.
CollaboratorINDUSTRY
Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frame
Force from femoral and tibial side to retract and bring visual field into viewintraoperatively

Secondary

MeasureTime frame
Incision lengthintraoperatively
Visual determination of the extension and flexion gapintraoperatively

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026