The Subvastus Approach in Total Knee Arthroplasty

This study is currently recruiting participants.

Verified by Capital District Health Authority, Canada, May 2008

Sponsored by:	Capital District Health Authority, Canada
Information provided by:	Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:	NCT00346788

Purpose

The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.

Condition	Intervention	Phase
Osteoarthritis	Procedure: Surgical approach for total knee arthroplasty	Phase IV

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	The Subvastus Approach in Total Knee Arthroplasty

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:

Length of hospital stay
Range of motion at discharge and six weeks post-operatively

Secondary Outcome Measures:

Wound complications
Post-operative narcotic use
Post-operative blood loss
The ability to straight-leg raise at two and twenty-four hours post-operatively
Knee Society Clinical Rating Scale
SF-12
WOMAC.

Estimated Enrollment:	126
Study Start Date:	January 2005

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

You are willing to take part in the study, including signing this form after carefully reading it.
You are available for follow-up for a minimum of 24 months (2 years).
You have no medical conditions that prevent you from having surgery.
This is the primary (first) knee replacement for this knee
You are fluent in English and are able to understand your responsibilities in this study.

Exclusion Criteria:

Active, local or systemic infection
Fibromyalgia or other chronic pain syndrome
Inability to follow the study requirements
Had this knee replaced before
Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
Body Mass Index (BMI) > 35, as you would not be eligible for the MIS approach.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346788

Contacts

Contact: Kelly Trask, B.Eng, MSc, CCRP

902-473-3161

kelly.trask@cdha.nshealth.ca

Locations

Canada, Nova Scotia
QEII Health Sciences Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Ross K Leighton, MD, FRCS(C)
Principal Investigator: Laurie W Barron, MD, FRCS(C)

Sponsors and Collaborators

Capital District Health Authority, Canada

Investigators

Principal Investigator:

Ross K Leighton, MD, FRCS(C)

Capital Health, Canada

More Information

Study ID Numbers:	CDHA-RL-001
Study First Received:	June 29, 2006
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00346788
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009