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Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

NCT06250530 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2027-01-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250530 on ClinicalTrials.gov