Skip to main content
OpenTrials
Completed

NCT Number: NCT00346788

The Subvastus Approach in Total Knee Arthroplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical approach for total knee arthroplasty

Procedure

total knee arthroplasty surgery using minimally invasive surgery or standard technique.

Primary outcomes

  1. Length of hospital stay

    Time frame: Post Operative

  2. Range of motion at discharge and six weeks post-operatively

    Time frame: Discharge and six weeks post operative

Secondary outcomes

  1. Wound complications

    Time frame: post operative until wound healed

  2. Post-operative narcotic use

    Time frame: 24 months post operative

  3. Post-operative blood loss

    Time frame: Post operative

  4. The ability to straight-leg raise at two and twenty-four hours post-operatively

    Time frame: 2 and 24 hours post operative

  5. Knee Society Clinical Rating Scale

    Time frame: pre-op, 6 months, 12 months, and 24 months post operative

  6. SF-12

    Time frame: pre-op, 6 months, 12 months, and 24 months post operative

  7. WOMAC.

    Time frame: pre-op, 6 months, 12 months, and 24 months post operative

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2006
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.