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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Deformity Knee
• Intervention / Treatment: Diagnostic test: X-rays: load bearing inferior limbs, lateral knee, axial patella

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulio Maria Marcheggiani Muccioli, MD PhD; Phone Number: 6509 051 636; Email: giuliomaria.marcheggianimuccioli@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • IRCCS Istituto Ortopedico Rizzoli
    • Contact: Giulio Maria Marcheggiani Muccioli, MD, PhD; Phone Number: +39 051 6366509; Email: marcheggianimuccioli@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lateral closing wedge high tibial osteotomy	Diagnostic test: X-rays: load bearing inferior limbs, lateral knee, axial patella; X-rays at 5 years follow-up minimum
Active Comparator: Medial opening wedge high tibial osteotomy	Diagnostic test: X-rays: load bearing inferior limbs, lateral knee, axial patella; X-rays at 5 years follow-up minimum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patellar height	RX measurement of patellar height	baseline time 0
femoral-patellar arthritis	RX evaluation of femoral-patellar arthritis	baseline time 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score	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.	baseline time 0
Kujala score	Assessment of patellofemoral disorders: subjective symptoms and functional limitations.	baseline time 0
Range of Motion	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.	baseline time 0

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: high tibial osteotomy; knee osteotomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HTO-FR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No