The Subvastus Approach in Total Knee Arthroplasty

February 14, 2025 updated by: Nova Scotia Health Authority
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIS
minimally invasive incision
Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
Active Comparator: Standard
Standard incision length
Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Post Operative
Post Operative
Range of motion at discharge and six weeks post-operatively
Time Frame: Discharge and six weeks post operative
Discharge and six weeks post operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound complications
Time Frame: post operative until wound healed
post operative until wound healed
Post-operative narcotic use
Time Frame: 24 months post operative
24 months post operative
Post-operative blood loss
Time Frame: Post operative
Post operative
The ability to straight-leg raise at two and twenty-four hours post-operatively
Time Frame: 2 and 24 hours post operative
2 and 24 hours post operative
Knee Society Clinical Rating Scale
Time Frame: pre-op, 6 months, 12 months, and 24 months post operative
pre-op, 6 months, 12 months, and 24 months post operative
SF-12
Time Frame: pre-op, 6 months, 12 months, and 24 months post operative
pre-op, 6 months, 12 months, and 24 months post operative
WOMAC.
Time Frame: pre-op, 6 months, 12 months, and 24 months post operative
pre-op, 6 months, 12 months, and 24 months post operative

Collaborators and Investigators

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

Sponsor

Nova Scotia Health Authority

Investigators

  • Principal Investigator: Ross K Leighton, MD, FRCS(C), Capital Health, Canada

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

January 1, 2005

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimated)

June 30, 2006

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RL-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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