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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00848133
Other study ID # Bonutti_SV_MV_001
Secondary ID
Status Completed
Phase Phase 4
First received February 19, 2009
Last updated February 19, 2009
Start date July 2004
Est. completion date February 2009

Study information

Verified date February 2009
Source Sinai Hospital of Baltimore
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare the early clinical outcomes of minimally invasive bilateral subvastus and midvastus approaches for total knee arthroplasty.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
mini-midvastus surgical approach for total knee arthroplasty

mini-subvastus surgical approach for total knee arthroplasty


Locations

Country Name City State
United States Bonutti Clinic Effingham Illinois

Sponsors (2)

Lead Sponsor Collaborator
Sinai Hospital of Baltimore Bonutti Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee Society Score Final follow-up (minimum 24 months) No
Secondary Radiographic alignment and fixation Final follow-up (minimum 24 months) No
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