Chondral Lesion of the KneeCARGEL-LTNCT06477315
Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures + BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee
An observational study of Chondral Lesion of the Knee and Patellofemoral Disorder, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The study consists of 3 phases (Identification of eligible patients, follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients): Identification by trained medical personnel of subjects who meet the study inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chondral Lesion of the Knee, Patellofemoral Disorder
- What is being tested?
- survey
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 22 Sep 2023to Jul 2029
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing treatment of osteochondral lesions of patellar cartilage by spinal cord stimulation with microfractures + BST CarGel
Who may be able to join
- Male or female patients, aged between 18 and 75 years;
- BMI up to 30 kg/m2;
- Patients without subsequent surgery on the patellofemoral cartilage of the knee undergoing treatment;
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
- Signature of informed consent
- availability
- Competent patients
Who cannot join
- Patients no longer available;
- Patients who do not agree to undergo assessment;
- Deceased patients
Trial locations and contacts
1 site in 1 country.
About this study
The study consists of 3 phases (Identification of eligible patients, follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients):
- Identification by trained medical personnel of subjects who meet the study inclusion criteria.
- Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted.
- Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures
- Being tested
- survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
telephone surveys
| Study group | Role | What they receive |
|---|---|---|
| post surgery patients | Not described Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. The questionnaire examines 3 categories: symptoms, sports activity and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, whereby a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.
Measured: baseline (post surgery)
Knee Injury and Osteoarthritis Outcome Score
The complete questionnaire consists of five subscales and covers: pain (9 items), symptoms (7 items of which two concern stiffness), functions and activities of daily living (17 items) physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). All items of the relevant subscales have the same response mode, use a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty".) Score range 0-100 for each subscale.
Measured: baseline (post surgery)
EuroQol visual analogue scale
It is a visual analogue scale that has a range of scores between 0 (worst imaginable health condition) and 100 (best imaginable health condition).
Measured: baseline (post surgery)
Tegner Score
allows one to estimate the motor activity level of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as football at national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
Measured: baseline (post surgery)
(EuroQoL) Current Health Assessment
valuable tool for measuring a patient's quality of life
Measured: baseline (post surgery)
Patient Acceptable Symptom State
Valuable tool for assessing patient satisfaction in view of their current degree of pain, function and daily activity
Measured: baseline (post surgery)
Final assessment of treatment
The patient should indicate satisfaction and the relative degree of satisfaction with the treatment after a minimum of 5 years after the infiltrative treatment.
Measured: baseline (post surgery)
failure question
the patient should indicate whether and when a new infiltrative or surgical treatment was performed. Questions will also be asked about possible complications and re-interventions
Measured: baseline (post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start22 Sep 2023
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
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 Chondral Lesion of the KneeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 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
- NCT06477315
- Sponsor's protocol ID
- CARGEL-LT
- Acronym
- CARGEL-LT
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Strauss EJ, Galos DK. The evaluation and management of cartilage lesions affecting the patellofemoral joint. Curr Rev Musculoskelet Med. 2013 Jun;6(2):141-9. doi: 10.1007/s12178-013-9157-z.
PubMed 23392780Duncan RC, Hay EM, Saklatvala J, Croft PR. Prevalence of radiographic osteoarthritis--it all depends on your point of view. Rheumatology (Oxford). 2006 Jun;45(6):757-60. doi: 10.1093/rheumatology/kei270. Epub 2006 Jan 17.
PubMed 16418199
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid- and Long-term Evaluation of the Results of Patients Undergoing Spinal Cord Stimulation With Microfractures + BST CarGel in the Treatment of Patellofemoral Chondral Lesions of the Knee
- ClinicalTrials.gov ID
- NCT06477315
- Acronym / sponsor ID
- CARGEL-LT / CARGEL-LT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 27 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 study consists of 3 phases (Identification of eligible patients, follow-up by telephone or telemedicine platform and the collection of study-specific clinical data of enrolled patients):
- Identification by trained medical personnel of subjects who meet the study inclusion criteria.
- Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted.
- Clinical score data will be collected from the questionnaires conducted at mid- and long-term follow-up of patients enrolled in the study. The data collected during the long-term follow-up will be used to evaluate the time course of the results obtained after treatment of osteochondral lesions of the patellar cartilage by spinal cord stimulation with microfractures
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post surgery patients | – | Other: survey |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment of osteochondral lesions of patellar cartilage by spinal cord stimulation with microfractures + BST CarGel
Key inclusion criteria (7 listed)
- Male or female patients, aged between 18 and 75 years;
- BMI up to 30 kg/m2;
- Patients without subsequent surgery on the patellofemoral cartilage of the knee undergoing treatment;
- Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;
- Signature of informed consent
Key exclusion criteria (3 listed)
- Patients no longer available;
- Patients who do not agree to undergo assessment;
- Deceased patients
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 |
|---|---|---|
| surveytelephone surveys | Other | post surgery patients |
Primary outcome
International Knee Documentation Committee
Time frame: baseline (post surgery)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. The questionnaire examines 3 categories: symptoms, sports activity and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, whereby a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms.
Knee Injury and Osteoarthritis Outcome Score
Time frame: baseline (post surgery)
The complete questionnaire consists of five subscales and covers: pain (9 items), symptoms (7 items of which two concern stiffness), functions and activities of daily living (17 items) physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). All items of the relevant subscales have the same response mode, use a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty".) Score range 0-100 for each subscale.
EuroQol visual analogue scale
Time frame: baseline (post surgery)
It is a visual analogue scale that has a range of scores between 0 (worst imaginable health condition) and 100 (best imaginable health condition).
Tegner Score
Time frame: baseline (post surgery)
allows one to estimate the motor activity level of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as football at national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
(EuroQoL) Current Health Assessment
Time frame: baseline (post surgery)
valuable tool for measuring a patient's quality of life
Patient Acceptable Symptom State
Time frame: baseline (post surgery)
Valuable tool for assessing patient satisfaction in view of their current degree of pain, function and daily activity
Final assessment of treatment
Time frame: baseline (post surgery)
The patient should indicate satisfaction and the relative degree of satisfaction with the treatment after a minimum of 5 years after the infiltrative treatment.
failure question
Time frame: baseline (post surgery)
the patient should indicate whether and when a new infiltrative or surgical treatment was performed. Questions will also be asked about possible complications and re-interventions
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 4 Jul 2025.
- Results publication: PubMed 23392780Strauss EJ, Galos DK. The evaluation and management of cartilage lesions affecting the patellofemoral joint. Curr Rev Musculoskelet Med. 2013 Jun;6(2):141-9. doi: 10.1007/s12178-013-9157-z.
- Results publication: PubMed 16418199Duncan RC, Hay EM, Saklatvala J, Croft PR. Prevalence of radiographic osteoarthritis--it all depends on your point of view. Rheumatology (Oxford). 2006 Jun;45(6):757-60. doi: 10.1093/rheumatology/kei270. Epub 2006 Jan 17.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Chondral Lesion of the Knee and Patellofemoral Disorder, 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Jul 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?
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?
International Knee Documentation Committee (time frame: baseline (post surgery)). The study lists 8 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 NCT06477315, 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 4 Jul 2025.