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The Subvastus Approach in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00346788
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE June 29, 2006
First Posted Date  ICMJE June 30, 2006
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE January 2005
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
  • Length of hospital stay [ Time Frame: Post Operative ]
  • Range of motion at discharge and six weeks post-operatively [ Time Frame: Discharge and six weeks post operative ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • Length of hospital stay
  • Range of motion at discharge and six weeks post-operatively
Change History Complete list of historical versions of study NCT00346788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2011)
  • Wound complications [ Time Frame: post operative until wound healed ]
  • Post-operative narcotic use [ Time Frame: 24 months post operative ]
  • Post-operative blood loss [ Time Frame: Post operative ]
  • The ability to straight-leg raise at two and twenty-four hours post-operatively [ Time Frame: 2 and 24 hours post operative ]
  • Knee Society Clinical Rating Scale [ Time Frame: 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 ]
  • WOMAC. [ Time Frame: pre-op, 6 months, 12 months, and 24 months post operative ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Subvastus Approach in Total Knee Arthroplasty
Official Title  ICMJE The Subvastus Approach in Total Knee Arthroplasty
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Procedure: Surgical approach for total knee arthroplasty
total knee arthroplasty surgery using minimally invasive surgery or standard technique.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2006)
126
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00346788
Other Study ID Numbers  ICMJE CDHA-RL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ross K. Leighton, Capital District Health Authority, Canada
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ross K Leighton, MD, FRCS(C) Capital Health, Canada
PRS Account Nova Scotia Health Authority
Verification Date May 2008

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