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

February 19, 2009 updated by: Sinai Hospital of Baltimore
The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Effingham, Illinois, United States, 62401
        • Bonutti Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee Society Score
Time Frame: Final follow-up (minimum 24 months)
Final follow-up (minimum 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiographic alignment and fixation
Time Frame: Final follow-up (minimum 24 months)
Final follow-up (minimum 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinai Hospital of Baltimore

Collaborators

Bonutti Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2009

Last Update Submitted That Met QC Criteria

February 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • Bonutti_SV_MV_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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