Cruciate Ligament RuptureNCT04184687
The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
A study testing Nanofractures and no treatment cartilaginous lesions in people with Cruciate Ligament Rupture and Cartilage Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cruciate Ligament Rupture, Cartilage Injury
- What is being tested?
- Nanofractures and no treatment cartilaginous lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2019to 10 Oct 2023
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients, 18 < age < 55;
- Patients with complete ACL injury candidates for surgical reconstruction of the same;
- Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively;
- Patients without evidence of osteoarthritis
- Patients' ability and consent to participate in clinical and radiological follow-up;
- Signature of informed consent.
Who cannot join
- Patients incapable of understanding and of wanting;
- State of immunodepression;
- Patients with malignant neoplasms;
- Patients suffering from rheumatic diseases;
- Patients suffering from non-compensated diabetes;
- Patients suffering from uncompensated thyroid metabolic disorders;
Show all 14Show fewer
- Patients abusing alcoholic beverages, drugs or drugs;
- Patients with axial deviations> 5 °;
- Body Mass Index> 35;
- Patients treated with surgery at the same knee in the previous 12 months.
- Cartilaginous lesions grade I-II according to the ICRS score.
- Cartilage lesions with a diameter greater than 3 cm².
- Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment.
- Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
Read the detailed description
The anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. The mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament.
The treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions.
In order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.
- Conditions
- Cruciate Ligament Rupture, Cartilage Injury
- Being tested
- Nanofractures, no treatment cartilaginous lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanofracturesProcedure or surgery
anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions
no treatment cartilaginous lesionsProcedure or surgery
patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions
| Study group | Role | What they receive |
|---|---|---|
| Nanofractures treatment of the cartilaginous lesions | Experimental | Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique. Receives: Procedure: Nanofractures |
| no treatment of the cartilaginous lesions | Active comparator | Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated Receives: Procedure: no treatment cartilaginous lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC-subjective score (International Knee Documentation Committee)
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
Measured: 24 month
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium)
Measured: 24 month
Secondary outcomes (4)
IKDC-subjective score (International Knee Documentation Committee)
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
Measured: 6, 12, 36 and 60 months
Tegner Activity Level Scale
Survey useful for assessing sport activity of the patient.
Measured: 6, 12, 24, 36 and 60 months
KOOS (Knee injury and Osteoarthritis Outcome Score )
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale
Measured: 6, 12, 24, 36 and 60 months
EQ-5D (EuroQoL) Current Health Assessment
It is a reliable tools for assessing quality of life of the patient
Measured: 6, 12, 24, 36 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start25 Jul 2019
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Why it stopped: The surgical procedures described in the study are performed outside the Institute
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cruciate Ligament RuptureStudies 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
- None (open label)
- Enrolment
- 4 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
- NCT04184687
- Sponsor's protocol ID
- CART-LCA
- Status last verified
- May 2026
- First submitted
- 28 Nov 2019
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filardo G, de Caro F, Andriolo L, Kon E, Zaffagnini S, Marcacci M. Do cartilage lesions affect the clinical outcome of anterior cruciate ligament reconstruction? A systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Oct;25(10):3061-3075. doi: 10.1007/s00167-016-4097-y. Epub 2016 Apr 4.
PubMed 27043346Brophy RH, Zeltser D, Wright RW, Flanigan D. Anterior cruciate ligament reconstruction and concomitant articular cartilage injury: incidence and treatment. Arthroscopy. 2010 Jan;26(1):112-20. doi: 10.1016/j.arthro.2009.09.002.
PubMed 20117635
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04184687
- Acronym / sponsor ID
- CART-LCA
- Conditions
- Cruciate Ligament Rupture, Cartilage Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The surgical procedures described in the study are performed outside the Institute
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 3 Dec 2019 (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 aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
Detailed description
The anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. The mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament.
The treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions.
In order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanofractures treatment of the cartilaginous lesions | Experimental | Procedure: NanofracturesPatients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique. |
| no treatment of the cartilaginous lesions | Active comparator | Procedure: no treatment cartilaginous lesionsPatients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female patients, 18 < age < 55;
- Patients with complete ACL injury candidates for surgical reconstruction of the same;
- Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively;
- Patients without evidence of osteoarthritis
- Patients' ability and consent to participate in clinical and radiological follow-up;
Key exclusion criteria (14 listed)
- Patients incapable of understanding and of wanting;
- State of immunodepression;
- Patients with malignant neoplasms;
- Patients suffering from rheumatic diseases;
- Patients suffering from non-compensated diabetes;
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 |
|---|---|---|
| Nanofracturesanterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions | Procedure or surgery | Nanofractures treatment of the cartilaginous lesions |
| no treatment cartilaginous lesionspatient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions | Procedure or surgery | no treatment of the cartilaginous lesions |
Primary outcome
IKDC-subjective score (International Knee Documentation Committee)
Time frame: 24 month
It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function.
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Time frame: 24 month
Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium)
4 secondary outcomes
IKDC-subjective score (International Knee Documentation Committee)
Time frame: 6, 12, 36 and 60 months
Tegner Activity Level Scale
Time frame: 6, 12, 24, 36 and 60 months
KOOS (Knee injury and Osteoarthritis Outcome Score )
Time frame: 6, 12, 24, 36 and 60 months
EQ-5D (EuroQoL) Current Health Assessment
Time frame: 6, 12, 24, 36 and 60 months
Results and safety
The study was stopped early (reason given: The surgical procedures described in the study are performed outside the Institute). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 27043346Filardo G, de Caro F, Andriolo L, Kon E, Zaffagnini S, Marcacci M. Do cartilage lesions affect the clinical outcome of anterior cruciate ligament reconstruction? A systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Oct;25(10):3061-3075. doi: 10.1007/s00167-016-4097-y. Epub 2016 Apr 4.
- Background: PubMed 20117635Brophy RH, Zeltser D, Wright RW, Flanigan D. Anterior cruciate ligament reconstruction and concomitant articular cartilage injury: incidence and treatment. Arthroscopy. 2010 Jan;26(1):112-20. doi: 10.1016/j.arthro.2009.09.002.
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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 Nanofractures and no treatment cartilaginous lesions in people with Cruciate Ligament Rupture and Cartilage Injury, 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 14 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: stopped early, as of the sponsor's last update on 22 May 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?
The study was stopped early (reason given: The surgical procedures described in the study are performed outside the Institute). Results are not available in the source record.
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?
IKDC-subjective score (International Knee Documentation Committee) (time frame: 24 month). 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 NCT04184687, which also lists 2 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 22 May 2026.