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NCT Number: NCT06251752

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Giulio Maria Marcheggiani Muccioli, MD, PhD

CONTACT

[email protected]

+39 051 6366509

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

X-rays at 5 years follow-up minimum

Primary outcomes

  1. patellar height

    Time frame: baseline time 0

    RX measurement of patellar height

  2. femoral-patellar arthritis

    Time frame: baseline time 0

    RX evaluation of femoral-patellar arthritis

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score

    Time frame: baseline time 0

    KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.

  2. Kujala score

    Time frame: baseline time 0

    Assessment of patellofemoral disorders: subjective symptoms and functional limitations.

  3. Range of Motion

    Time frame: baseline time 0

    ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid.

Study contacts

Contact information is provided by the study sponsor or research team.

Giulio Maria Marcheggiani Muccioli, MD PhD

CONTACT

[email protected]

051 636 ext. 6509

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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