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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00925626
First received: June 19, 2009
Last updated: October 15, 2010
Last verified: October 2010

June 19, 2009
October 15, 2010
June 2009
August 2010   (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 ] [ Designated as safety issue: No ]
  • Rehabilitation time; time needed for 90° flexion of the knee joint [ Time Frame: post-operatively ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
  • Amount and type of analgesic drugs used. [ Time Frame: pre-operatively and post-operatively ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 2010
August 2010   (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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00925626
2009/256
No
Peter Verdonk, MD, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Peter Verdonk, MD University Hospital, Ghent
University Hospital, Ghent
October 2010

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