Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

NCT06250530 | Not Yet Recruiting

• 1 other identifier: REB #120983
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteotomy; Malalignment, Bone; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• KOOS

  The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain, other symptoms, function in daily living, function in sports/recreation and knee-related quality of life. Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). This instrument has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and is responsive to change.

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes (4)

• EQ-5D (Index and VAS)

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Procedure Time

  Surgery

• Adverse Events

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

• Cost Effectiveness

  Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

BodyCAD

EXPERIMENTAL

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).

Procedure: High tibial osteotomy using BodyCAD

TOMOFIX

ACTIVE COMPARATOR

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.

Procedure: High tibial osteotomy using TOMOFIX

Interventions

High tibial osteotomy using TOMOFIX 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.

Also known as: TOMOFIX

TOMOFIX

High tibial osteotomy using BodyCAD 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.

Also known as: BodyCAD

BodyCAD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Bone Malalignment; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Central Study Contacts

Stacey Wanlin

CONTACT

519-661-2111; swanlin@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: February 9, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share