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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014