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

This study has been completed.
Biomet Japan, Inc.
Information provided by (Responsible Party):
Zimmer Biomet Identifier:
First received: November 9, 2009
Last updated: October 15, 2012
Last verified: October 2012
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.

Condition Intervention
Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement Procedure: Incision technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Force from femoral and tibial side to retract and bring visual field into view [ Time Frame: intraoperatively ]

Secondary Outcome Measures:
  • Incision length [ Time Frame: intraoperatively ]
  • Visual determination of the extension and flexion gap [ Time Frame: intraoperatively ]

Enrollment: 72
Study Start Date: November 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tri-Vector Approach Procedure: Incision technique
Tri-Vector Approach retains the majority of 3 vectors of quadriceps.
Experimental: Mini Mid-Vastus Approach Procedure: Incision technique
Mini Mid-Vastus Approach


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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.)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01010828

National Hospital Organization, Osaka National Hospital
Osaka, Japan, 540-0006
Sponsors and Collaborators
Zimmer Biomet
Biomet Japan, Inc.
  More Information

Responsible Party: Zimmer Biomet Identifier: NCT01010828     History of Changes
Other Study ID Numbers: JP12
Study First Received: November 9, 2009
Last Updated: October 15, 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 17, 2017