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NCT05865899: HTO-IOR
Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis.
NA trial testing valgus producing medial opening wedge high tibial osteotomy in Knee Osteoarthritis in 50 participants. Completed in 3 December 2024.
22 March 2023
Quick facts
| Lead sponsor | Istituto Ortopedico Rizzoli |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 17 May 2021 |
| Primary completion | 22 March 2023 |
| Estimated completion | 3 December 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- valgus producing medial opening wedge high tibial osteotomy
Conditions studied
- Knee Osteoarthritis — all drugs for Knee Osteoarthritis →
- Cartilage Degeneration — all drugs for Cartilage Degeneration →
- Malalignment, Bone — all drugs for Malalignment, Bone →
Sponsor
Istituto Ortopedico Rizzoli — full company profile →
Who can join
Adults 40 to 65, any sex, with Knee Osteoarthritis or Cartilage Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
High tibial osteotomy (HTO) surgical procedure can lead to clinically significant improvements in the cartilage and in subchondral bone quality, with a slow down of the osteoarthritis (OA) progression. Aim of the project is to: (i) clinically validate a 3D planned HTO surgical approach, through a quantitative grading of OA progression in a prospective randomized case-control clinical trial; (ii) correlate the internal knee loads with the changes assessed in cartilage and subchondral bone status to verify the hypothesis that HTO induced mechanical changes are associated with clinically significant OA improvements; (iii) relate imaging data with cartilage and subchondral bone mechanical properties, in order to classify OA progression in a more sensitive manner and allow a more precise diagnosis of the pathology stage.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Altered motor function during daily activities in patients eligible for high tibial osteotomy is primarily driven by knee varus deformity.
Valente G, Grenno G, Benedetti MG, Dal Fabbro G, et al · · 2025 · cited 2× · PMID 40246300 · DOI 10.1302/2633-1462.64.bjo-2024-0189.r1 -
High tibial osteotomy effectively restores motor function during daily activities in patients with knee osteoarthritis and varus deformity.
Valente G, Grenno G, Dal Fabbro G, Grassi A, et al · · 2025 · cited 1× · PMID 40959213 · DOI 10.1002/jeo2.70410
Verify or expand the search:
- PubMed search for NCT05865899
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Istituto Ortopedico Rizzoli trials
Trials by the same sponsor.
- NCT07590882 — Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study · enrolling by invitation
- NCT07021222 — Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaF · NA · recruiting
- NCT07360964 — Clear Cell Chondrosarcoma in Italy · NA · active not recruiting
- NCT07140367 — "Transarterial Microembolization (TAME) in Inflammatory Knee Pathology" · recruiting
- NCT07102875 — Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases · NA · active not recruiting
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 NCT05865899 (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 Istituto Ortopedico Rizzoli
- Last refreshed: 17 January 2025
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/NCT05865899.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing