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
  Purpose

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".


Condition Intervention
Tricompartmental Gonarthrosis
Procedure: Sub-Vastus arthrotomy
Procedure: Mid - Vastus arthrotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sub - Vastus arthrotomy
Sub-vastus arthrotomy
Procedure: Sub-Vastus arthrotomy
Sub-vastus arthrotomy
Active Comparator: Mid-Vastus arthrotomy
Mid-vastus arthrotomy
Procedure: Mid - Vastus arthrotomy
Mid-vastus arthrotomy

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925626

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Peter Verdonk, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Peter Verdonk, MD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00925626     History of Changes
Other Study ID Numbers: 2009/256
Study First Received: June 19, 2009
Last Updated: October 15, 2010
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014