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

This study has been completed.
Sponsor:
Collaborator:
Biomet Japan, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01010828
First received: November 9, 2009
Last updated: October 15, 2012
Last verified: October 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Force from femoral and tibial side to retract and bring visual field into view [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incision length [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
  • Visual determination of the extension and flexion gap [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010828

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01010828     History of Changes
Other Study ID Numbers: JP12
Study First Received: November 9, 2009
Last Updated: October 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 18, 2014