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

This study has been completed.

First Received: February 19, 2009 No Changes Posted

Sponsors and Collaborators:	Sinai Hospital of Baltimore Bonutti Clinic
Information provided by:	Sinai Hospital of Baltimore
ClinicalTrials.gov Identifier:	NCT00848133

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Subvastus and Midvastus Approaches in Minimally-Invasive Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Surgery

U.S. FDA Resources

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
mini-midvastus: Active Comparator	Procedure: mini-midvastus surgical approach for total knee arthroplasty
mini-subvastus: Active Comparator	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

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

ClinicalTrials.gov processed this record on August 30, 2009