Completed

NCT Number: NCT00925626

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

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".

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tricompartmental Gonarthrosis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sub-Vastus arthrotomy

Procedure

Sub-vastus arthrotomy

Mid - Vastus arthrotomy

Procedure

Mid-vastus arthrotomy

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Jun 22, 2009
Registry last updated: Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.