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

NCT06251752 | Recruiting

• 1 other identifier: HTO-FR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deformity Knee; Knee Osteoarthritis

Keywords

knee osteotomy; high tibial osteotomy

Outcome Measures

Primary Outcomes (2)

• patellar height

  RX measurement of patellar height

  baseline time 0

• femoral-patellar arthritis

  RX evaluation of femoral-patellar arthritis

  baseline time 0

Secondary Outcomes (3)

• Knee injury and Osteoarthritis Outcome Score

  baseline time 0

• Kujala score

  baseline time 0

• Range of Motion

  baseline time 0

Study Arms (2)

Lateral closing wedge high tibial osteotomy

ACTIVE COMPARATOR

Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella

Medial opening wedge high tibial osteotomy

ACTIVE COMPARATOR

Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella

Interventions

X-rays: load bearing inferior limbs, lateral knee, axial patella DIAGNOSTIC_TEST

X-rays at 5 years follow-up minimum

Lateral closing wedge high tibial osteotomy; Medial opening wedge high tibial osteotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• Coventry MB. Upper tibial osteotomy for osteoarthritis. J Bone Joint Surg Am. 1985 Sep;67(7):1136-40. No abstract available.

  PMID: 4030836 RESULT

• 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 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Giulio Maria Marcheggiani Muccioli, MD PhD

CONTACT

051 636; giuliomaria.marcheggianimuccioli@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cohort 1: lateral closing wedge high tibial osteotomy cohort 2: medial opening wedge high tibial osteotomy

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 9, 2024
• Study Start: October 22, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)