Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis.

NCT05865899 | Completed DMC

• 1 other identifier: RF-2018-12368274
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

High tibial osteotomy (HTO) surgical procedure can lead to clinically significant improvements in the cartilage and in subchondral bone quality, with a slow down of the osteoarthritis (OA) progression. Aim of the project is to: (i) clinically validate a 3D planned HTO surgical approach, through a quantitative grading of OA progression in a prospective randomized case-control clinical trial; (ii) correlate the internal knee loads with the changes assessed in cartilage and subchondral bone status to verify the hypothesis that HTO induced mechanical changes are associated with clinically significant OA improvements; (iii) relate imaging data with cartilage and subchondral bone mechanical properties, in order to classify OA progression in a more sensitive manner and allow a more precise diagnosis of the pathology stage.

Conditions

Knee Osteoarthritis; Cartilage Degeneration; Malalignment, Bone

Keywords

Knee; Osteoarthritis; Varus; Malalignment; Cartilage; Correction Accuracy

Outcome Measures

Primary Outcomes (5)

• Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI).

  Baseline and one-year follow-up cartilage status will be assessed in order to detect changes in cartilage status after the treatment. Quantitative cartilage assessment will be perfomed using T1rho and T2 mapping sequences which will be gathered during MRI.

  3 years

• Subchondral bone morphological and structural analysis via Cone Bean Computed Tomography (CBCT) of the knee.

  Baseline and one-year follow-up subchondral bone morphological and structural features will be assessed via CBCT analysis, which allow to perform a weight-bearing assessment of the knee bone status and morphology.

  3 years

• Clinical Score for Knee function 1

  Marx Activity Rating Scale (MARS) score is an outcome reporting measure to evaluate the activity level of patients with various knee disorders who participate in sports. The MARS focuses on four activity points: running, deceleration, cutting (changing directions while running) and pivoting. MARS form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.

  3 years

• Clinical Score for Knee function 2

  The Knee Injury and Osteoarthritis Outcome score KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.

  3 years

• Clinical Score for Knee function 3

  IKDC Subjective and objective Knee Evaluation Form. The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. IKDC evaluation form will be assessed at baseline, six-months and 1-year follow-up. Higher scores mean a better outcome, lower scores mean a worse outcome.

  3 years

Secondary Outcomes (3)

• Gait analysis assessment

  3 years

• Scores for general health

  3 years

• Scores for pain

  3 years

Study Arms (2)

surgical

EXPERIMENTAL

patients who undergo high tibial osteotomy procedure

Procedure: valgus producing medial opening wedge high tibial osteotomy

conservative

NO INTERVENTION

patients who undergo conservative treatment

Interventions

valgus producing medial opening wedge high tibial osteotomy PROCEDURE

Valgus producing Opening wedge high tibial osteotomy will be performed through a medial incision at the proximal tibia and stabilized with a plate and screws. Hardware will be removed within 10-12 months to avoid soft tissue irritation.

surgical

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medial knee osteoarthritis in varus knee malalignment (\> 4°)

You may not qualify if:

• Inability to sign informed consent
• joint infection
• inflammatory chronic disease
• previous major surgical procedure of the indexed knee (simple arthroscopy or meniscectomy would be not considered major procedure)
• BMI \> 30

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Stefano Zaffagnini

Bologna, 40135, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Bone Malalignment; Osteoarthritis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 19, 2023
• Study Start: May 17, 2021
• Primary Completion: March 22, 2023
• Study Completion: December 3, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)