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

NCT06462625 | Recruiting

• 1 other identifier: KNEE OSTEOTOMY-OA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Malalignment, Bone

Outcome Measures

Primary Outcomes (1)

• Lysholm Knee Score

  It is a validated measurement scale that assesses knee functionality through 8 items, which help determine the condition of the knee in response to the functional demands of daily activities. This evaluation form is commonly used to assess the outcomes of surgery in patients who have undergone operations for ligament or meniscal injuries of the knee. The final score is obtained by summing the various scores from the different items and ranges from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).

  24 months after surgery

Secondary Outcomes (10)

• International Knee Documentation Committee (IKDC)

  24 months after surgery

• Objective IKDC(IKDC standard evaluation form)

  24 months after surgery

• VAS (visual analog scale)

  24 months after surgery

• SF-36 (Short Form-36 Health Survey)

  24 months after surgery

• Tegner Score

  24 months after surgery

Study Arms (2)

Closing wedge

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

Other: High tibial osteotomy

Opening wedge

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

Other: High tibial osteotomy

Interventions

High tibial osteotomy OTHER

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

Closing wedge; Opening wedge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on the number of patients treated at Rizzoli with this type of surgical intervention and considering a 25% dropout rate, it is estimated that 150 patients with a follow-up period of 2 to 20 years can be included in the study. It is noteworthy that previous studies with similar aims have a patient sample similar to that proposed by the current study.

You may qualify if:

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

You may not qualify if:

• Patients with advanced multicompartimental osteoarthritis;
• Patients who are no longer reachable;
• Women of childbearing age who cannot exclude pregnancy;
• Patients unable to give informed consent or patients unwilling to sign the informed consent form.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Bone Malalignment

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases

Central Study Contacts

Stefano Zaffagnini

CONTACT

0516366075; stefano.zaffagnini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: January 12, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)