Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorVestre Viken Hospital Trust

About this trial

The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55% correction is non-inferior to aiming at 62%.

Eligibility criteria

Qualifiers

Patients having accepted and signed the informed consent form before surgery

Patients aged 30-60 years

Patients with an indication for primary HTO based on anamnestic, clinical and radiological findings leading to the diagnosis of major medial knee compartment overload symptoms

Mechanical varus axis of 3-9 deg. (calculated on full length weightbearing X-ray (FLWB))

Disqualifiers

Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)

Patients using Prednisolone perorally

Smokers (need to quit preoperatively)

Significant overweight (Body Mass Index > 35)

Trial design

Treatments tested in this trial

  • Procedure: HTO using PSI aiming at 55% correction
  • Procedure: HTO using PSI aiming at 62% correction

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Vestre Viken Hospital Trust

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator

Oslo University Hospital

Collaborator

Lovisenberg Diakonale Hospital

Collaborator