Knee OsteoarthritisKNEE OSTEOTOMYNCT06462625
Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement
An observational study of Knee Osteoarthritis and Malalignment, Bone, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Malalignment, Bone
- What is being tested?
- High tibial osteotomy
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2023to Oct 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Stefano Zaffagnini, 0516366075, stefano.zaffagnini@ior.it
About this study
Official title: Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
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
- Being tested
- High tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee, Bone Malalignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyOther
Correction of lower limb malalignement with tibial bone wedge insertion/removal
| Study group | Role | What they receive |
|---|---|---|
| Closing wedge | Patients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement Receives: Other: High tibial osteotomy | |
| Opening wedge | Patients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement Receives: Other: High tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months after surgery
Secondary outcomes (10)
International Knee Documentation Committee (IKDC)
The IKDC form is a subjective knee evaluation module that reflects the limitations on activities an individual can perform in daily life and sports, as well as the presence or absence of symptoms. There are three main domains of the IKDC evaluation form: Symptoms, which include pain, stiffness, swelling, and a sense of locking; Sports and daily activities; Current knee function and function before the injury. The questionnaire consists of 10 questions: seven items investigate the patient's symptoms, one item addresses sports participation, one item-comprising 9 points-concerns the difficulties the patient experiences in performing daily activities, and the last item measures the current functionality of the knee.
The score ranges from 0 to 100, with 100 representing the absence of limitations and symptoms; the further away from this score, the worse the result. The scores can be divided into four groups: excellent (80-100), good (60-80), fair (30-60), and poor (0-30).
Measured: 24 months after surgery
Objective IKDC(IKDC standard evaluation form)
It represents a clinical form completed by the physician following a thorough objective examination of the knee, during which various clinical tests are performed to evaluate potential joint deformities, objective instability, and meniscal injuries. The obtained score determines an objective evaluation grade codified using Roman letters. According to this scale, grade "A" is assigned to a knee with "normal, healthy" functionality, grade "B" is assigned to a knee with "nearly normal" functionality, grade "C" is assigned to a knee with "moderately abnormal" functionality, and grade "D" is assigned to a knee with "severely abnormal" functionality.
Measured: 24 months after surgery
VAS (visual analog scale)
It is a unidimensional quantitative numeric pain rating scale with 10 points. The scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that specific moment. 0 means no pain and 10 indicates the worst possible pain.
Measured: 24 months after surgery
SF-36 (Short Form-36 Health Survey)
It is the most well-known and widely used health-related quality of life measurement tool in international literature. It assesses various health concepts through 36 multiple-choice questions, with the data aggregated into 8 scales that investigate: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Additionally, there is one question about changes in health status over the past year.
Measured: 24 months after surgery
Tegner Score
It allows for the estimation of a subject's level of physical activity with a score ranging from 0 to 10, where 0 represents 'incapacity' and 10 represents 'participation in competitive sports, such as national or international level soccer.' This score is the most commonly used to define the level of physical activity in patients with knee disorders. Additionally, the patient will be asked how many years they have been active in sports and whether the reason for reducing or ceasing activity is related to knee pathology or not.
Measured: 24 months after surgery
Hip circonference
Measuring the thigh circumference at 5 cm and 15 cm above the superior pole of the patella allows for the assessment of muscle trophism in the subjects under examination, thereby evaluating the potential influence of the technique used on the knee's extensor apparatus.
Measured: 24 months after surgery
Anterior knee pain / pain during knee flexion
To specifically assess the symptoms of the femoropatellar joint, patients will be asked to answer these questions in a dichotomous manner (YES/NO).
Measured: 24 months after surgery
Patient satisfaction
In order to assess the level of patient satisfaction, they will be asked to respond to the question "Are you satisfied with the surgical intervention?" Once again, the response will be dichotomous.
Measured: 24 months after surgery
Radiographic evaluation
The study will collect clinical and imaging data from patients to assess the development of osteoarthritis and other radiographic anomalies. If patients lack radiological documentation according to the study protocol post-intervention, weight-bearing lower limb X-rays and lateral projection X-rays of the operated knee will be conducted to evaluate osteoarthritis severity using the Kellgren-Lawrence scale. This scale categorizes osteoarthritis into 5 grades based on joint space reduction and osteophyte presence. Additionally, computer-assisted quantitative analyses will be performed on radiographic images at the collaborating facility for precise measurement of pre- and post-operative joint angles.
Measured: 24 months after surgery
Complications or subsequent interventions
Any complications and subsequent interventions will be documented and recorded in the Case Report Form (CRF).
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start12 Jan 2023
- Primary completion1 Jun 2024
- Study completionOct 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462625
- Sponsor's protocol ID
- KNEE OSTEOTOMY-OA
- Acronym
- KNEE OSTEOTOMY
- Status last verified
- Jan 2026
- First submitted
- 12 Jun 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
- ClinicalTrials.gov ID
- NCT06462625
- Acronym / sponsor ID
- KNEE OSTEOTOMY / KNEE OSTEOTOMY-OA
- Conditions
- Knee Osteoarthritis, Malalignment, Bone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Jun 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closing wedge | – | Other: High tibial osteotomyPatients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement |
| Opening wedge | – | Other: High tibial osteotomyPatients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| High tibial osteotomyCorrection of lower limb malalignement with tibial bone wedge insertion/removal | Other | Closing wedge, Opening wedge |
Primary outcome
Lysholm Knee Score
Time frame: 24 months after surgery
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).
10 secondary outcomes
International Knee Documentation Committee (IKDC)
Time frame: 24 months after surgery
Objective IKDC(IKDC standard evaluation form)
Time frame: 24 months after surgery
VAS (visual analog scale)
Time frame: 24 months after surgery
SF-36 (Short Form-36 Health Survey)
Time frame: 24 months after surgery
Tegner Score
Time frame: 24 months after surgery
Hip circonference
Time frame: 24 months after surgery
Anterior knee pain / pain during knee flexion
Time frame: 24 months after surgery
Patient satisfaction
Time frame: 24 months after surgery
Radiographic evaluation
Time frame: 24 months after surgery
Complications or subsequent interventions
Time frame: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Malalignment, Bone, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Zaffagnini (0516366075, stefano.zaffagnini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Score (time frame: 24 months after surgery). 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 29 Jan 2026.