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Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00925626
First Posted: June 22, 2009
Last Update Posted: June 4, 2015
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.
Information provided by:
University Hospital, Ghent
June 19, 2009
June 22, 2009
June 4, 2015
June 2009
August 2015   (Final data collection date for primary outcome measure)
  • VAS, KOOS and HSS scales [ Time Frame: at day 1, day 2, day 3, day 4 and day 5 post-operatively ]
  • Rehabilitation time; time needed for 90° flexion of the knee joint [ Time Frame: post-operatively ]
Same as current
Complete list of historical versions of study NCT00925626 on ClinicalTrials.gov Archive Site
  • VAS, HSS, KOOS questionnaires [ Time Frame: at 6 weeks, 3 months and 12 months after surgery. ]
  • Amount and type of analgesic drugs used. [ Time Frame: pre-operatively and post-operatively ]
Same as current
Not Provided
Not Provided
 
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Tricompartmental Gonarthrosis
  • Procedure: Sub-Vastus arthrotomy
    Sub-vastus arthrotomy
  • Procedure: Mid - Vastus arthrotomy
    Mid-vastus arthrotomy
  • Experimental: Sub - Vastus arthrotomy
    Sub-vastus arthrotomy
    Intervention: Procedure: Sub-Vastus arthrotomy
  • Active Comparator: Mid-Vastus arthrotomy
    Mid-vastus arthrotomy
    Intervention: Procedure: Mid - Vastus arthrotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
100
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients diagnosed with osteoarthrosis of the knee
  • patients must be in good general health condition

Exclusion Criteria:

  • patients with morbid obesity (BMI >45)
  • patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00925626
2009/256
No
Not Provided
Not Provided
Peter Verdonk, MD, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Peter Verdonk, MD University Hospital, Ghent
University Hospital, Ghent
June 2015

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