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

This study has been completed.
Sponsor:
Collaborator:
Bonutti Clinic
Information provided by:
Sinai Hospital of Baltimore
ClinicalTrials.gov Identifier:
NCT00848133
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic alignment and fixation [ Time Frame: Final follow-up (minimum 24 months) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Peter Bonutti, MD, Bonutti Clinic
ClinicalTrials.gov Identifier: NCT00848133     History of Changes
Other Study ID Numbers: Bonutti_SV_MV_001
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014