Knee Arthritis OsteoarthritisMONO-LCANCT07377669
A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study
An observational study of Knee Arthritis Osteoarthritis and Cruciate Ligament Rupture, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis Osteoarthritis, Cruciate Ligament Rupture
- What is being tested?
- UKA + ACLr
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 31 Dec 2026
- How long will I take part?
- 1 Year
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by monocompartimental knee arthosis and ACL complete lesion in the same knee who underwent simoultaneous one stage ACLr + UKA
Who may be able to join
- monocompartimental knee arthrosis and ACL complete lesion
- High functional request
- Follow up >12 m
- Complete clinical and radiographic documentation
- Patients who accepted to partecipate to the study
- Patients who did non underwent surgical procedures in the controlateral knee
Who cannot join
- two stage surgeries (UKA and ACLr)
- patients affected by neuromuscolar disorders, or psychomotor disorders
- further knee ligamentous associated lesions
- revision surgery
- low functional request due to comorbilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction
Read the detailed description
The aim is to understand if anterior cruciate ligament recontruction is mandatory in case of monocompartimental knee replacement, given the fact that anterior stability could be compromised at first in ACL (anterior cruciate ligament) deficient knees. Current datas in literature are not sufficient to establish if ACL must always be recontructed or if only in some cases
- Being tested
- UKA + ACLr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UKA + ACLrProcedure or surgery
Simultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| UKA + LCA patients | Patients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement Receives: Procedure: UKA + ACLr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tegner-Lysholm score
The Tegner Lysholm Knee Scoring Scale is a questionnaire used to assess knee function and symptoms, particularly in the context of ligament injuries of the knee. It evaluates eight categories: pain, swelling, instability, locking, limp, stair climbing, squatting, and need for support. Each category is scored, and the total score, out of 100, reflects overall knee function. Higher scores indicate better knee function.
Measured: 12 months after surgery
Secondary outcomes (7)
SF-36
It consists of 36 questions assessing the patient's general health, divided into eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The score ranges from a minimum of 0 to a maximum of 100 and has been validated in Italian.
Measured: 12 months after surgery
Ucla
It is a questionnaire used to define activity levels after knee arthroplasty. It is patient-reported and provides a score ranging from 1 to 10. It has also been validated in Italian.
Measured: 12 months after surgery
Return to Sport
Number of months elapsed before returning to sports activity (if resumed). Sports activities are classified according to Veil et al. into low-intensity, potentially low-intensity, intermediate-intensity, and high-intensity categories.
Measured: 12 months after surgery
New KSS
A self-administered knee function and outcome assessment test. Validation in Italian is still ongoing.
Measured: 12 months after surgery
Vas
Subjective pain assessment scale
Measured: 12 months after surgery
KT-1000
An objective tool for assessing anteroposterior knee laxity
Measured: 12 months after surgery
ROM
Active and passive range of motion
Measured: 12 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 posted30 Jan 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis 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
- 15 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
- Investigators
- Stefano Zaffagnini, Full Professor, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377669
- Sponsor's protocol ID
- MONO-LCA
- Acronym
- MONO-LCA
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Study: Monocompartimental Knee Arthroplasty Combined With Anterior Cruciate Ligament Reconstruction Surgery - a Pilot Study
- ClinicalTrials.gov ID
- NCT07377669
- Acronym / sponsor ID
- MONO-LCA / MONO-LCA
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
This study aims to collect datas about patient who underwent simultaneous monocompartimental knee replacement and anterior cruciate ligament recontruction
Detailed description
The aim is to understand if anterior cruciate ligament recontruction is mandatory in case of monocompartimental knee replacement, given the fact that anterior stability could be compromised at first in ACL (anterior cruciate ligament) deficient knees. Current datas in literature are not sufficient to establish if ACL must always be recontructed or if only in some cases
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UKA + LCA patients | – | Procedure: UKA + ACLrPatients who underwent simultaneous anterior cruciate ligament and monocompartimental knee replacement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by monocompartimental knee arthosis and ACL complete lesion in the same knee who underwent simoultaneous one stage ACLr + UKA
Key inclusion criteria (6 listed)
- monocompartimental knee arthrosis and ACL complete lesion
- High functional request
- Follow up >12 m
- Complete clinical and radiographic documentation
- Patients who accepted to partecipate to the study
Key exclusion criteria (5 listed)
- two stage surgeries (UKA and ACLr)
- patients affected by neuromuscolar disorders, or psychomotor disorders
- further knee ligamentous associated lesions
- revision surgery
- low functional request due to comorbilities
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 |
|---|---|---|
| UKA + ACLrSimultaneous ACL reconstruction and Unicompartmental Knee Arthroplasty | Procedure or surgery | UKA + LCA patients |
Primary outcome
Tegner-Lysholm score
Time frame: 12 months after surgery
The Tegner Lysholm Knee Scoring Scale is a questionnaire used to assess knee function and symptoms, particularly in the context of ligament injuries of the knee. It evaluates eight categories: pain, swelling, instability, locking, limp, stair climbing, squatting, and need for support. Each category is scored, and the total score, out of 100, reflects overall knee function. Higher scores indicate better knee function.
7 secondary outcomes
SF-36
Time frame: 12 months after surgery
Ucla
Time frame: 12 months after surgery
Return to Sport
Time frame: 12 months after surgery
New KSS
Time frame: 12 months after surgery
Vas
Time frame: 12 months after surgery
KT-1000
Time frame: 12 months after surgery
ROM
Time frame: 12 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 30 Jan 2026.
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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.
Stefano Zaffagnini, Full Professor principal investigator
Istituto Ortopedico Rizzoli
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 Arthritis Osteoarthritis and Cruciate Ligament Rupture, 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 6 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: enrolling by invitation, as of the sponsor's last update on 30 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?
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?
Tegner-Lysholm score (time frame: 12 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 30 Jan 2026.