Status:
NOT_YET_RECRUITING
Finding the Optimal Aim of Correction in Opening Wedge High Tibial Osteotomy
Lead Sponsor:
Vestre Viken Hospital Trust
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
Oslo University Hospital
Conditions:
Osteoarthritis, Knee
Knee Pain Chronic
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
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%.
Detailed Description
HTO should play a major role in modern treatment algorithms for knee overload and osteoarthritis. By transferring load from the failing/osteoarthritic compartment of the knee to a healthier compartmen...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06134050
Start Date
November 1 2023
End Date
October 1 2028
Last Update
November 18 2023
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