NCT06250530

Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteotomy
• Malalignment, Bone
• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	High tibial osteotomy using TOMOFIX	TOMOFIX: A guidepin is placed to determine the level and length of the osteotomy with an appropriate hinge position selected. The oscillating saw is then used along with osteotomes to complete the osteotomy under image intensifier guidance. This is opened to the desired width of correction with a trapezoidal gap noted when using laminar spreader in the posterior position to avoid slope change. The plate is then applied and secured as per manufacturers operative technique.
PROCEDURE	High tibial osteotomy using BodyCAD	BodyCAD: The patient specific cutting block is applied to the proximal tibia and secured in placed. The osteotomy is then created with sequential drills and osteotome and opened to the predetermined correction as per the manufacturer's guidelines. The plate is applied and secured with the supplied screws.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2024-02-09
• Last updated: 2024-04-26