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NCT05865899: HTO-IOR

Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis.

Completed NA Last updated 17 January 2025
What this trial tests

NA trial testing valgus producing medial opening wedge high tibial osteotomy in Knee Osteoarthritis in 50 participants. Completed in 3 December 2024.

Timeline
17 May 2021
Primary endpoint
22 March 2023
3 December 2024

Quick facts

Lead sponsorIstituto Ortopedico Rizzoli
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment50
Start date17 May 2021
Primary completion22 March 2023
Estimated completion3 December 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Istituto Ortopedico Rizzoli trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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