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The Subvastus Approach in Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00346788
First received: June 29, 2006
Last updated: June 27, 2011
Last verified: May 2008

June 29, 2006
June 27, 2011
January 2005
March 2011   (final data collection date for primary outcome measure)
  • Length of hospital stay [ Time Frame: Post Operative ] [ Designated as safety issue: No ]
  • Range of motion at discharge and six weeks post-operatively [ Time Frame: Discharge and six weeks post operative ] [ Designated as safety issue: No ]
  • Length of hospital stay
  • Range of motion at discharge and six weeks post-operatively
Complete list of historical versions of study NCT00346788 on ClinicalTrials.gov Archive Site
  • Wound complications [ Time Frame: post operative until wound healed ] [ Designated as safety issue: Yes ]
  • Post-operative narcotic use [ Time Frame: 24 months post operative ] [ Designated as safety issue: Yes ]
  • Post-operative blood loss [ Time Frame: Post operative ] [ Designated as safety issue: Yes ]
  • The ability to straight-leg raise at two and twenty-four hours post-operatively [ Time Frame: 2 and 24 hours post operative ] [ Designated as safety issue: No ]
  • Knee Society Clinical Rating Scale [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]
  • WOMAC. [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
The Subvastus Approach in Total Knee Arthroplasty
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
  • Experimental: MIS
    minimally invasive incision
    Intervention: Procedure: Surgical approach for total knee arthroplasty
  • Active Comparator: Standard
    Standard incision length
    Intervention: Procedure: Surgical approach for total knee arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00346788
CDHA-RL-001
No
Ross K. Leighton, Capital District Health Authority, Canada
Capital District Health Authority, Canada
Not Provided
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
Capital District Health Authority, Canada
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP