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Recruiting NCT06251752

Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy

No phase Interventional Knee Osteoarthritis Deformity Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: X-rays: load bearing inferior limbs, lateral knee, axial patella.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Deformity Knee. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. They serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand. Medial knee osteoarthritis is a pathology increasingly prevalent in today's population. The resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. Osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement. The two most commonly used techniques are the Closing Wedge Lateral High Tibial Osteotomy (LCW-HTO) and the Opening Wedge Medial High Tibial Osteotomy (MOW-HTO), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively. The medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. However, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.

Interventions

  • Diagnostic test X-rays: load bearing inferior limbs, lateral knee, axial patella
    X-rays at 5 years follow-up minimum

Primary outcome measures

  • patellar height [Time frame: baseline time 0]
  • femoral-patellar arthritis [Time frame: baseline time 0]
Secondary outcome measures (3)
  • Knee injury and Osteoarthritis Outcome Score [Time frame: baseline time 0]
  • Kujala score [Time frame: baseline time 0]
  • Range of Motion [Time frame: baseline time 0]

Eligibility criteria

Inclusion criteria

  • Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV)
  • Follow-up > 60 months
  • Completeness of clinical and radiographic documentation.
  • Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO)
  • Age <65 years

Exclusion criteria

  • Patients with previous injuries affecting the involved lower limb.
  • Patients with prior traumatic, septic, and rheumatoid arthritis.
  • Patients with previous alterations of the patellofemoral joint.
  • Patients with knee ligament injuries.
  • Patients with confirmed neuromuscular disorders or psychomotor disturbances.
  • Patients with congenital generalized hypermobility syndrome.
  • Patients with severe pathologies in other organs or systems limiting activities of daily living (ADL).
  • Patients who refuse to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Rizzoli — Bologna

Publications

  • Brouwer RW, Huizinga MR, Duivenvoorden T, van Raaij TM, Verhagen AP, Bierma-Zeinstra SM, Verhaar JA. Osteotomy for treating knee osteoarthritis. Cochrane Database Syst Rev. 2014 Dec 13;2014(12):CD004019. doi: 10.1002/14651858.CD004019.pub4. PMID 25503775
  • Coventry MB. Upper tibial osteotomy for osteoarthritis. J Bone Joint Surg Am. 1985 Sep;67(7):1136-40. No abstract available. PMID 4030836
  • Amendola A, Bonasia DE. Results of high tibial osteotomy: review of the literature. Int Orthop. 2010 Feb;34(2):155-60. doi: 10.1007/s00264-009-0889-8. Epub 2009 Oct 17. PMID 19838706

Identifiers

NCT: NCT06251752 · HTO-FR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗