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

July 5, 2021 updated by: University Hospital, Ghent

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS, KOOS and HSS scales
Time Frame: at day 1, day 2, day 3, day 4 and day 5 post-operatively
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
post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS, HSS, KOOS questionnaires
Time Frame: at 6 weeks, 3 months and 12 months after surgery.
at 6 weeks, 3 months and 12 months after surgery.
Amount and type of analgesic drugs used.
Time Frame: pre-operatively and post-operatively
pre-operatively and post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Peter Verdonk, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2009

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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