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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010828
First Posted: November 10, 2009
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biomet Japan, Inc.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010828


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01010828     History of Changes
Other Study ID Numbers: JP12
First Submitted: November 9, 2009
First Posted: November 10, 2009
Last Update Posted: October 16, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases