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

Launched by MARTINA HANSEN'S HOSPITAL · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a surgical procedure called high tibial osteotomy (HTO), which is used to relieve knee pain caused by osteoarthritis. The study aims to find out if using 3D-printed guides to correct the knee alignment by 55% is just as effective as correcting it by 62%. This is important because it could help doctors determine the best way to perform the surgery to improve outcomes for patients.

To be eligible for this study, participants should be between the ages of 30 and 60 and have knee problems mainly affecting the inner part of the knee. They also need to have a specific type of knee alignment issue that can be corrected with this surgery. However, people with certain conditions like inflammatory arthritis, those who smoke, or have significant weight issues may not qualify. If you decide to participate, you’ll need to sign a consent form and will have the opportunity to help researchers learn more about this procedure, which could lead to better treatments for knee pain in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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))
• • Correctable angular deformity on the tibia only (medial proximal tibial angle (MPTA) + planned correction \< 95 deg. Lateral distal femoral angle (LDFA) \<92 deg.)
• • Maximal calculated gap height 14 mm
• • Only the first knee will be included if later contralateral HTO
• Exclusion Criteria:
• • Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)
• • Patients using Prednisolone perorally
• • Smokers (need to quit preoperatively)
• • Significant overweight (Body Mass Index \> 35)
• • Earlier fractures in affected leg with fracture malalignment \>5 deg.
• • Extension deficit \>10 deg. in the affected knee
• • Earlier septic arthritis/osteomyelitis in the affected leg
• • Previous major surgery affecting leg function. Earlier knee arthroscopic procedures like ACL-reconstruction are not excluded
• • Planned combined procedures involving HTO + ACL/PCL-reconstruction, meniscal transplantation or meniscal root fixation is excluded
• • Neurologic disease with symptoms affecting the leg
• • Serious illness or other factors that make communication, follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease, non-Norwegian speakers).