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Clinical Trials/NCT01010828
NCT01010828
Completed
Not Applicable

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

Zimmer Biomet1 site in 1 country72 target enrollmentOctober 1, 2009
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ConditionsGonarthrosis Patients Who Need Artificial Knee Joint Total Replacement

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement
Sponsor
Zimmer Biomet
Enrollment
72
Locations
1
Primary Endpoint
Force from femoral and tibial side to retract and bring visual field into view
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2009
End Date
March 31, 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.)

Outcomes

Primary Outcomes

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

Time Frame: intraoperatively

Secondary Outcomes

  • Incision length(intraoperatively)
  • Visual determination of the extension and flexion gap(intraoperatively)

Study Sites (1)

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