Knee OsteoarthritisHTO-IORNCT05865899
Impact of High Tibial Osteotomy in Preventing Degenerative Disease Progression in Medial Knee Osteoarthritis.
A study testing valgus producing medial opening wedge high tibial osteotomy in people with Knee Osteoarthritis and Cartilage Degeneration, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Degeneration, Malalignment, Bone
- What is being tested?
- valgus producing medial opening wedge high tibial osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2021to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medial knee osteoarthritis in varus knee malalignment (> 4°)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of High Tibial Osteotomy in Preventing Disease Progression in Medial Knee Osteoarthritis: Quantifying the Effects on Cartilage and Subchondral Bone by Using a Combined Biomechanical and Medical Imaging Approach.
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.
Read the detailed description
High tibial osteotomy (HTO) is a well tracked procedure aimed to reduce the overload in the medial compartment of the varus knee with early and mid-stage osteoarthritits (OA).
Clear evidence still lacks regarding whether it has the ability to determine regenerative processes in the cartilage and subchondral bone. Furthermore, prospective randomised analysis regarding the effectiveness of HTO with respect to conservative treatment are needed.
The hypothesis is that an accurately planned HTO surgery result in measurable changes in the internal knee biomechanics, leading to clinically significant improvements in cartilage and subchondral bone quality, slowing down OA progression.
Accurate HTO could thus become the first choice in young/fit patients with medial knee OA, preserving their bone stock, slowing down OA progression and eventually reversing its trend, with a high impact on patients' quality of life and on public health system spending.
Aims of the study:
- To quantify by quantitative imaging and subject-specific modeling the biomechanical changes induced in patients' joint by accurate HTO surgery, and the consequent changes of articular tissues composition and structure, related to OA progression.
- To evaluate the surgical accuracy of a new 3D HTO planning system. Once association of biomechanical corrections with clinical outcome is established (Aim 1), such 3D HTO planning will help surgeons performing personalized HTO corrections.
- To define an enhanced methodology for OA staging, by correlating quantitative medical imaging with mechanical properties of cartilage and subchondral bone.
Metodologies and statistical analyses:
Sample Size:The primary outcome of the study is the clinical assessment of cartilage/subchondral bone. In absence of standard subchondral bone scores, sample size has been determined on MRI T2 relaxometry, a reliable quantitative descriptor of cartilage in OA. Power analysis, based on cartilage T2 variations due to HTO (Independent t test, T2 expected difference 3.5 ms, standard deviation 4.5 ms, significance level 0.05, power 0.8, one tail), indicated 44 patients (22 per group). We target to enroll 50 patients to compensate for possible drop-outs.
Surgical technique: opening wedge HTO will be performed through a medial incision and stabilized with a plate and screws. Hardware will be removed within 10-12 months to avoid soft tissue irritation.
Imaging assessment: cartilage morphology and composition will be assessed via T1rho and T2 mapping from 3T MRI. Subchondral bone density and orientation will be computed from CBCT images. To quantify the biomechanical changes induced by HTO, subject-specific musculoskeletal models of the lower limbs will be created from MRI with nmsBuilder freeware, and used to calculate (with OpenSim software) knee loads during daily motor activities from marker trajectories and ground reaction forces measured in the gait analysis. A knee joint model enabling calculation of cartilage contact pressure will be implemented. Arthroscopic assessment of cartilage will follow the International Cartilage Repair Society (ICRS) score. Histological analysis of cartilage biopsies will be performed.
- Being tested
- valgus producing medial opening wedge high tibial osteotomy
- Keywords
- Knee, Osteoarthritis, Varus, Malalignment, Cartilage, Correction Accuracy
- Medical subject headings
- Osteoarthritis, Knee, Bone Malalignment, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valgus producing medial opening wedge high tibial osteotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| surgical | Experimental | patients who undergo high tibial osteotomy procedure Receives: Procedure: valgus producing medial opening wedge high tibial osteotomy |
| conservative | No intervention | patients who undergo conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Secondary outcomes (3)
Gait analysis assessment
Gait analysis will be assessed at baseline and at one-year follow-up in order to detect changes in gait pattern after the treatment. The active movements will be assessed by gait analysis tracking systems to quantify gait pattern.
Measured: 3 years
Scores for general health
Short- form survey (SF-12) is composed by two summary scores: a mental component score (MCS-12) and a physical component score (PCS-12). Higher scores mean a better outcome, lower scores mean a worse outcome.
Measured: 3 years
Scores for pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start17 May 2021
- Primary completion22 Mar 2023
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865899
- Sponsor's protocol ID
- RF-2018-12368274
- Acronym
- HTO-IOR
- Status last verified
- Jan 2025
- First submitted
- 23 Mar 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Tibial Osteotomy in Preventing Disease Progression in Medial Knee Osteoarthritis: Quantifying the Effects on Cartilage and Subchondral Bone by Using a Combined Biomechanical and Medical Imaging Approach.
- ClinicalTrials.gov ID
- NCT05865899
- Acronym / sponsor ID
- HTO-IOR / RF-2018-12368274
- Keywords
- Knee, Osteoarthritis, Varus, Malalignment, Cartilage, Correction Accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High tibial osteotomy (HTO) is a well tracked procedure aimed to reduce the overload in the medial compartment of the varus knee with early and mid-stage osteoarthritits (OA).
Clear evidence still lacks regarding whether it has the ability to determine regenerative processes in the cartilage and subchondral bone. Furthermore, prospective randomised analysis regarding the effectiveness of HTO with respect to conservative treatment are needed.
The hypothesis is that an accurately planned HTO surgery result in measurable changes in the internal knee biomechanics, leading to clinically significant improvements in cartilage and subchondral bone quality, slowing down OA progression.
Accurate HTO could thus become the first choice in young/fit patients with medial knee OA, preserving their bone stock, slowing down OA progression and eventually reversing its trend, with a high impact on patients' quality of life and on public health system spending.
Aims of the study:
- To quantify by quantitative imaging and subject-specific modeling the biomechanical changes induced in patients' joint by accurate HTO surgery, and the consequent changes of articular tissues composition and structure, related to OA progression.
- To evaluate the surgical accuracy of a new 3D HTO planning system. Once association of biomechanical corrections with clinical outcome is established (Aim 1), such 3D HTO planning will help surgeons performing personalized HTO corrections.
- To define an enhanced methodology for OA staging, by correlating quantitative medical imaging with mechanical properties of cartilage and subchondral bone.
Metodologies and statistical analyses:
Sample Size:The primary outcome of the study is the clinical assessment of cartilage/subchondral bone. In absence of standard subchondral bone scores, sample size has been determined on MRI T2 relaxometry, a reliable quantitative descriptor of cartilage in OA. Power analysis, based on cartilage T2 variations due to HTO (Independent t test, T2 expected difference 3.5 ms, standard deviation 4.5 ms, significance level 0.05, power 0.8, one tail), indicated 44 patients (22 per group). We target to enroll 50 patients to compensate for possible drop-outs.
Surgical technique: opening wedge HTO will be performed through a medial incision and stabilized with a plate and screws. Hardware will be removed within 10-12 months to avoid soft tissue irritation.
Imaging assessment: cartilage morphology and composition will be assessed via T1rho and T2 mapping from 3T MRI. Subchondral bone density and orientation will be computed from CBCT images. To quantify the biomechanical changes induced by HTO, subject-specific musculoskeletal models of the lower limbs will be created from MRI with nmsBuilder freeware, and used to calculate (with OpenSim software) knee loads during daily motor activities from marker trajectories and ground reaction forces measured in the gait analysis. A knee joint model enabling calculation of cartilage contact pressure will be implemented. Arthroscopic assessment of cartilage will follow the International Cartilage Repair Society (ICRS) score. Histological analysis of cartilage biopsies will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical | Experimental | Procedure: valgus producing medial opening wedge high tibial osteotomypatients who undergo high tibial osteotomy procedure |
| conservative | No intervention | –patients who undergo conservative treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medial knee osteoarthritis in varus knee malalignment (> 4°)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valgus producing medial opening wedge high tibial osteotomyValgus 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. | Procedure or surgery | surgical |
Primary outcome
Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI).
Time frame: 3 years
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.
Subchondral bone morphological and structural analysis via Cone Bean Computed Tomography (CBCT) of the knee.
Time frame: 3 years
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.
Clinical Score for Knee function 1
Time frame: 3 years
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.
Clinical Score for Knee function 2
Time frame: 3 years
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.
Clinical Score for Knee function 3
Time frame: 3 years
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 secondary outcomes
Gait analysis assessment
Time frame: 3 years
Scores for general health
Time frame: 3 years
Scores for pain
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valgus producing medial opening wedge high tibial osteotomy in people with Knee Osteoarthritis and Cartilage Degeneration, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartilage morphology and composition assessment via T1rho and T2 mapping from 3Tesla (3T) magnetic resonance imaging(MRI). (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.