Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

Western University, Canada

Status: Not yet enrolling

Conditions: Malalignment, Bone; Osteotomy; Osteoarthritis, Knee

Treatments: Procedure: High tibial osteotomy using TOMOFIX; Procedure: High tibial osteotomy using BodyCAD

Study type: Interventional

Funder types: Other

Identifiers

NCT06250530

REB #120983

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

BodyCAD

Experimental group

Description:

For participants randomized to BodyCAD Fine osteotomy, the HKA radiographs and CT scans will be sent to the manufacturer via a secure weblink as per SoC. The films will be used to calculate the desired correction and the instruments and implants manufactured accordingly. The mechanical medial proximal tibial angle (mMPTA) will be recorded for both pre- and planned post-operative situations and used to determine the accuracy of correction (primary outcome).

Treatment:

Procedure: High tibial osteotomy using BodyCAD

TOMOFIX

Active Comparator group

Description:

For participants randomized to the TOMOFIX system, preoperative planning will use the HKA radiograph. DICOM images will be transported to MEDICAD software program in which alignment angles and alignment correction will be calculated. The mMPTA will again be utilised to determine the accuracy of correction (primary outcome). The preop CT scan will also be used as per the BodyCAD system and the same indices calculated so as to minimise measurement bias between two different imaging modalities. However, the results of the preoperative 3D CT planning will not be made available to the operating surgeon, again to minimise bias between groups.

Treatment:

Procedure: High tibial osteotomy using TOMOFIX