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

ConditionsOsteoarthritis, Knee Knee Pain Chronic Arthralgia

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Procedure: HTO using PSI aiming at 55% correction
Procedure/Surgery
HTO using PSI designed to achieve correction to 55% tibial width.
Procedure: HTO using PSI aiming at 62% correction
Procedure/Surgery
HTO using PSI designed to achieve correction to 62% tibial width.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: 55% correctionExperimental treatment 1 intervention

Group B: 62% correctionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Knee injury and Osteoarthritis Outcome Score subscore Quality of Life (KOOS QOL), 0-100, 100 best score

Knee related Quality of Life

Time frame

24 months

Secondary outcomes

Knee injury and Osteoarthritis Outcome Score 12 Short form (KOOS-12), 0-100, 100 best score

Knee related pain, symptoms, ADL, QoL and function

Time frame

24 months

Forgotten Joint Score-12(FJS-12), 0-100, 100 best score

Knee related symptoms and function

Time frame

24 months

EuroQol-5D (EQ-5D), index 0-1, 1 best score

Health related quality of life

Time frame

24 months

University of California at Los Angeles activity level (UCLA), 0-10, 10 most active

Activity level score

Time frame

24 months

Other outcomes

HKA X-ray measures (Standing Hip-Knee-Ankle x-ray)

MPTA/JLCA/LDFA/HKA angles

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vestre Viken Hospital Trust

Lead sponsor

South-Eastern Norway Regional Health Authority

Collaborator

Oslo University Hospital

Collaborator

Lovisenberg Diakonale Hospital

Collaborator

Source ClinicalTrials.gov

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