Comparison Between TOMOFIX and BodyCAD Fine Osteotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWestern University, Canada
About this trial
This is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (MOWHTO) to either current standard of care with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. If the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.
Eligibility criteria
Qualifiers
aged 18-70 years old
have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
able to speak, read and understand English
Disqualifiers
found to have a cruciate ligament deficiency
require multiplanar or rotational alignment correction
have greater than 5 degrees fixed flexion deformity
unable to have CT scans for follow up
Trial design
Treatments tested in this trial
- High tibial osteotomy using TOMOFIX
- High tibial osteotomy using BodyCAD
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov