Knee OsteoarthritisNCT06251752
Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy
A study testing X-rays: load bearing inferior limbs, lateral knee, axial patella in people with Knee Osteoarthritis and Deformity Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Deformity Knee
- What is being tested?
- X-rays: load bearing inferior limbs, lateral knee, axial patella
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 22 Oct 2020to Dec 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV)
- Follow-up > 60 months
- Completeness of clinical and radiographic documentation.
- Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO)
- Age <65 years
Who cannot join
- Patients with previous injuries affecting the involved lower limb.
- Patients with prior traumatic, septic, and rheumatoid arthritis.
- Patients with previous alterations of the patellofemoral joint.
- Patients with knee ligament injuries.
- Patients with confirmed neuromuscular disorders or psychomotor disturbances.
- Patients with congenital generalized hypermobility syndrome.
- Patients with severe pathologies in other organs or systems limiting activities of daily living (ADL).
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulio Maria Marcheggiani Muccioli, MD PhD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Giulio Maria Marcheggiani Muccioli, MD, PhD, +39 051 6366509, marcheggianimuccioli@me.com
About this study
Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. They serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand.
Medial knee osteoarthritis is a pathology increasingly prevalent in today's population. The resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. Osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement.
Read more
The two most commonly used techniques are the Closing Wedge Lateral High Tibial Osteotomy (LCW-HTO) and the Opening Wedge Medial High Tibial Osteotomy (MOW-HTO), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively.
The medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. However, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.
- Conditions
- Knee Osteoarthritis, Deformity Knee
- Being tested
- X-rays: load bearing inferior limbs, lateral knee, axial patella
- Keywords
- knee osteotomy, high tibial osteotomy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rays: load bearing inferior limbs, lateral knee, axial patellaDiagnostic test
X-rays at 5 years follow-up minimum
| Study group | Role | What they receive |
|---|---|---|
| Lateral closing wedge high tibial osteotomy | Active comparator | Not described Receives: Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella |
| Medial opening wedge high tibial osteotomy | Active comparator | Not described Receives: Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella |
What is being measured
The primary outcome is the main question the study is designed to answer.
patellar height
RX measurement of patellar height
Measured: baseline time 0
femoral-patellar arthritis
RX evaluation of femoral-patellar arthritis
Measured: baseline time 0
Secondary outcomes (3)
Knee injury and Osteoarthritis Outcome Score
KOOS assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: baseline time 0
Kujala score
Assessment of patellofemoral disorders: subjective symptoms and functional limitations.
Measured: baseline time 0
Range of Motion
ROM expresses in degrees the degree of range of motion that a joint can perform along its full range of motion whether active or passive through an external aid.
Measured: baseline time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start22 Oct 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- cohort 1: lateral closing wedge high tibial osteotomy cohort 2: medial opening wedge high tibial osteotomy
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251752
- Sponsor's protocol ID
- HTO-FR
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brouwer RW, Huizinga MR, Duivenvoorden T, van Raaij TM, Verhagen AP, Bierma-Zeinstra SM, Verhaar JA. Osteotomy for treating knee osteoarthritis. Cochrane Database Syst Rev. 2014 Dec 13;2014(12):CD004019. doi: 10.1002/14651858.CD004019.pub4.
PubMed 25503775Coventry MB. Upper tibial osteotomy for osteoarthritis. J Bone Joint Surg Am. 1985 Sep;67(7):1136-40. No abstract available.
PubMed 4030836Amendola A, Bonasia DE. Results of high tibial osteotomy: review of the literature. Int Orthop. 2010 Feb;34(2):155-60. doi: 10.1007/s00264-009-0889-8. Epub 2009 Oct 17.
PubMed 19838706
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT06251752
- Acronym / sponsor ID
- HTO-FR
- Conditions
- Knee Osteoarthritis, Deformity Knee
- Keywords
- knee osteotomy, high tibial osteotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Feb 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.
Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. They serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand.
Medial knee osteoarthritis is a pathology increasingly prevalent in today's population. The resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. Osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement.
The two most commonly used techniques are the Closing Wedge Lateral High Tibial Osteotomy (LCW-HTO) and the Opening Wedge Medial High Tibial Osteotomy (MOW-HTO), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively.
The medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. However, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cohort 1: lateral closing wedge high tibial osteotomy cohort 2: medial opening wedge high tibial osteotomy
| Arm | Type | Receives |
|---|---|---|
| Lateral closing wedge high tibial osteotomy | Active comparator | Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella |
| Medial opening wedge high tibial osteotomy | Active comparator | Diagnostic Test: X-rays: load bearing inferior limbs, lateral knee, axial patella |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV)
- Follow-up > 60 months
- Completeness of clinical and radiographic documentation.
- Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO)
- Age <65 years
Key exclusion criteria (8 listed)
- Patients with previous injuries affecting the involved lower limb.
- Patients with prior traumatic, septic, and rheumatoid arthritis.
- Patients with previous alterations of the patellofemoral joint.
- Patients with knee ligament injuries.
- Patients with confirmed neuromuscular disorders or psychomotor disturbances.
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 |
|---|---|---|
| X-rays: load bearing inferior limbs, lateral knee, axial patellaX-rays at 5 years follow-up minimum | Diagnostic test | Lateral closing wedge high tibial osteotomy, Medial opening wedge high tibial osteotomy |
Primary outcome
patellar height
Time frame: baseline time 0
RX measurement of patellar height
femoral-patellar arthritis
Time frame: baseline time 0
RX evaluation of femoral-patellar arthritis
3 secondary outcomes
Knee injury and Osteoarthritis Outcome Score
Time frame: baseline time 0
Kujala score
Time frame: baseline time 0
Range of Motion
Time frame: baseline time 0
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 23 Feb 2026.
- Background: PubMed 25503775Brouwer RW, Huizinga MR, Duivenvoorden T, van Raaij TM, Verhagen AP, Bierma-Zeinstra SM, Verhaar JA. Osteotomy for treating knee osteoarthritis. Cochrane Database Syst Rev. 2014 Dec 13;2014(12):CD004019. doi: 10.1002/14651858.CD004019.pub4.
- Results publication: PubMed 4030836Coventry MB. Upper tibial osteotomy for osteoarthritis. J Bone Joint Surg Am. 1985 Sep;67(7):1136-40. No abstract available.
- Results publication: PubMed 19838706Amendola A, Bonasia DE. Results of high tibial osteotomy: review of the literature. Int Orthop. 2010 Feb;34(2):155-60. doi: 10.1007/s00264-009-0889-8. Epub 2009 Oct 17.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Giulio Maria Marcheggiani Muccioli, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-rays: load bearing inferior limbs, lateral knee, axial patella in people with Knee Osteoarthritis and Deformity Knee, 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 5 inclusion and 8 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 23 Feb 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 Giulio Maria Marcheggiani Muccioli, MD PhD (051 636 ext. 6509, giuliomaria.marcheggianimuccioli@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patellar height (time frame: baseline time 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06251752, which also lists 3 linked publications.
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 23 Feb 2026.