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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251752
• Other study ID #: HTO-FR
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Giulio Maria Marcheggiani Muccioli, MD PhD
• Phone: 051 636
• Email: giuliomaria.marcheggianimuccioli[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deformity Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patellar height	RX measurement of patellar height	baseline time 0
Primary	femoral-patellar arthritis	RX evaluation of femoral-patellar arthritis	baseline time 0
Secondary	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
Secondary	Kujala score	Assessment of patellofemoral disorders: subjective symptoms and functional limitations.	baseline time 0
Secondary	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