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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06251752
Enrollment
50
Registered
2024-02-09
Start date
2020-10-22
Completion date
2026-12-01
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deformity Knee, Knee Osteoarthritis

Keywords

knee osteotomy, high tibial osteotomy

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.

Interventions

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

X-rays at 5 years follow-up minimum

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV) 2. Follow-up \> 60 months 3. Completeness of clinical and radiographic documentation. 4. Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO) 5. Age \<65 years

Exclusion criteria

1. Patients with previous injuries affecting the involved lower limb. 2. Patients with prior traumatic, septic, and rheumatoid arthritis. 3. Patients with previous alterations of the patellofemoral joint. 4. Patients with knee ligament injuries. 5. Patients with confirmed neuromuscular disorders or psychomotor disturbances. 6. Patients with congenital generalized hypermobility syndrome. 7. Patients with severe pathologies in other organs or systems limiting activities of daily living (ADL). 8. Patients who refuse to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
patellar heightbaseline time 0RX measurement of patellar height
femoral-patellar arthritisbaseline time 0RX evaluation of femoral-patellar arthritis

Secondary

MeasureTime frameDescription
Range of Motionbaseline time 0ROM 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.
Knee injury and Osteoarthritis Outcome Scorebaseline time 0KOOS 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.
Kujala scorebaseline time 0Assessment of patellofemoral disorders: subjective symptoms and functional limitations.

Countries

Italy

Contacts

CONTACTGiulio Maria Marcheggiani Muccioli, MD PhD
giuliomaria.marcheggianimuccioli@ior.it051 636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026