Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement

NCT ID: NCT06462625

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-12

Study Completion Date

2027-10-31

Brief Summary

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The present study aims to evaluate the long-term and medium-term outcomes of different knee osteotomy techniques in the treatment of knee osteoarthritis in patients with lower limb malalignment. This evaluation is necessary in the current context of research on the treatment and prevention of knee osteoarthritis through treatments that do not involve or allow for the postponement of prosthetic replacement. Among the biological treatments performed in orthopedic clinical practice, osteotomy is one of the most promising. However, further long-term evaluations are needed to more clearly determine the indications and potential of this type of intervention, considering the various surgical procedures described for performing it.

Detailed Description

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Conditions

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Knee Osteoarthritis Malalignment, Bone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Closing wedge

Patients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement

High tibial osteotomy

Intervention Type OTHER

Correction of lower limb malalignement with tibial bone wedge insertion/removal

Opening wedge

Patients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement

High tibial osteotomy

Intervention Type OTHER

Correction of lower limb malalignement with tibial bone wedge insertion/removal

Interventions

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High tibial osteotomy

Correction of lower limb malalignement with tibial bone wedge insertion/removal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment;
2. Patients aged between 18 and 70 years at the time of surgical intervention;
3. Patients with isolated compartmental osteoarthritis;
4. Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality.

Exclusion Criteria

1. Patients with advanced multicompartimental osteoarthritis;
2. Patients who are no longer reachable;
3. Women of childbearing age who cannot exclude pregnancy;
4. Patients unable to give informed consent or patients unwilling to sign the informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Stefano Zaffagnini

Role: CONTACT

0516366075

Facility Contacts

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Stefano Zaffagnini

Role: primary

0516366075

Other Identifiers

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KNEE OSTEOTOMY-OA

Identifier Type: -

Identifier Source: org_study_id

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