Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

NCT ID: NCT06250530

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-06-30

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.

Conditions

Osteotomy; Malalignment, Bone; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BodyCAD

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).

Group Type: EXPERIMENTAL

High tibial osteotomy using BodyCAD

Intervention Type: PROCEDURE

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.

TOMOFIX

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.

Group Type: ACTIVE_COMPARATOR

High tibial osteotomy using TOMOFIX

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

TOMOFIX; BodyCAD

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Al Getgood

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Stacey Wanlin

Role: CONTACT

swanlin@uwo.ca

519-661-2111 ext. 82705

Other Identifiers

REB #120983

Identifier Type: -

Identifier Source: org_study_id