Clinical trial NCT06250530: Comparison Between TOMOFIX and BodyCAD Fine Osteotomy
Official title: Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteotomy
Malalignment, Bone
Osteoarthritis, Knee
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.

Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.

If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.

Eligibility criteria: Inclusion Criteria:

* aged 18-70 years old
* have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
* able to speak, read and understand English

Exclusion Criteria:

* 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
* evidence of tricompartmental osteoarthritis
* evidence of lateral compartment osteoarthritis on arthroscopy
* received injection therapy within 3 months of surgery on the operative knee
* have a medical history of inflammatory arthropathy, diabetes
* actively smoke

Primary outcomes:
measure: KOOS
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: EQ-5D (Index and VAS)
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Procedure Time
timeFrame: Surgery
measure: Adverse Events
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Cost Effectiveness
timeFrame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
References: