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A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848133
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
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:
Bonutti Clinic
Information provided by:
Sinai Hospital of Baltimore
  Purpose
The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.

Condition Intervention Phase
Total Knee Arthroplasty Procedure: mini-midvastus surgical approach for total knee arthroplasty Procedure: mini-subvastus surgical approach for total knee arthroplasty Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Sinai Hospital of Baltimore:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: Final follow-up (minimum 24 months) ]

Secondary Outcome Measures:
  • Radiographic alignment and fixation [ Time Frame: Final follow-up (minimum 24 months) ]

Enrollment: 51
Study Start Date: July 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: mini-midvastus Procedure: mini-midvastus surgical approach for total knee arthroplasty
Active Comparator: mini-subvastus Procedure: mini-subvastus surgical approach for total knee arthroplasty

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with advanced bilateral osteoarthritis of the knee for treatment with total knee arthroplasty
  • patients who wish to undergo bilateral total knee arthroplasty as part of a single surgical procedure

Exclusion Criteria:

  • patients who were previously treated with knee arthroplasty
  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): NCT00848133


Locations
United States, Illinois
Bonutti Clinic
Effingham, Illinois, United States, 62401
Sponsors and Collaborators
Sinai Hospital of Baltimore
Bonutti Clinic
Investigators
Principal Investigator: Michael A Mont, MD Sinai Hospital of Baltimore
  More Information

Responsible Party: Peter Bonutti, MD, Bonutti Clinic
ClinicalTrials.gov Identifier: NCT00848133     History of Changes
Other Study ID Numbers: Bonutti_SV_MV_001
First Submitted: February 19, 2009
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
Last Verified: February 2009


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