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NCT04000672: ProtectedHTO

Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT)

Completed NA Last updated 7 December 2023
What this trial tests

NA trial testing 3D printed patient specific metal jigs (PSI jig) in Osteotomy in 40 participants. Completed in 6 December 2023.

Timeline
1 July 2019
Primary endpoint
6 December 2023
6 December 2023

Quick facts

Lead sponsorChinese University of Hong Kong
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment40
Start date1 July 2019
Primary completion6 December 2023
Estimated completion6 December 2023
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 70, any sex, with Osteotomy or Randomized Controlled Trial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Medial open wedge high tibial osteotomy is a surgery performed to treat knee osteoarthritis in young patients.Recently with our department advance of technology, the investigators performed computed tomography for the patient's lower limb and 3D reconstruct the image. Based on the 3D image, the investigators planned our planned osteotomy cut on computer software Materialize 3 and the investigators then 3D printed a metal jig that has a slot to produce the osteotomy and also protected the neurovascular bundles. Therefore these metal jigs are specific to each patients. The investigators have performed a few cases of HTO under this extra metal jig protection and guidance and noted it has improved accuracy and safety clinically. However, whether it has scientific significance difference in accuracy is not known.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Patient-specific instrumentation (PSI) Referencing High Tibial Osteotomy Technological Transfer and Education: protocol for a double-blind, randomised controlled trial (PROTECTED HTO Trial).
    Lau LCM, Chui ECS, Fan JCH, Man GCW, et al · · 2021 · cited 8× · PMID 33550239 · DOI 10.1136/bmjopen-2020-041129

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Other recruiting trials for Osteotomy

Currently open trials in the same condition.

Other Chinese University of Hong Kong trials

Trials by the same sponsor.

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Data sources for this page

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