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NCT04000672: ProtectedHTO
Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT)
NA trial testing 3D printed patient specific metal jigs (PSI jig) in Osteotomy in 40 participants. Completed in 6 December 2023.
6 December 2023
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 July 2019 |
| Primary completion | 6 December 2023 |
| Estimated completion | 6 December 2023 |
| Sites | 1 location across Hong Kong |
Drugs / interventions tested
- 3D printed patient specific metal jigs (PSI jig)
- HTO with navigation
Conditions studied
- Osteotomy — all drugs for Osteotomy →
- Randomized Controlled Trial — all drugs for Randomized Controlled Trial →
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):
-
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
Verify or expand the search:
- PubMed search for NCT04000672
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Chinese University of Hong Kong trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04000672 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 7 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04000672.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing