Cartilage DamageNCT05660161
This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
A study testing Nanofracture in people with Cartilage Damage, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
Articular cartilage lesions, with their inherent limited healing potential, remain a challenging problem for orthopaedic surgeons. Various techniques, both palliative and reparative, have been used to treat this injury with variable success rates. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Cartilage Damage
- What is being tested?
- Nanofracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Mar 2023to Jan 2028
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with cartilage lesions of the knee scheduled for surgery
- Age 16-50
- BMI between 18.5 and 30 points
- Ability to give informed consent
Who cannot join
- Uncorrected knee instability
- Meniscectomy > 50%
- Uncorrected knee misalignment
- Uncontrolled metabolic diseases
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
EOC
Lugano, 6900
Christian Candrian, MD, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
About this study
Official title: A Pilot Study to Evaluate the Functional Outcome of Nanofractures for the Treatment of Cartilage Lesions
Articular cartilage lesions, with their inherent limited healing potential, remain a challenging problem for orthopaedic surgeons. Various techniques, both palliative and reparative, have been used to treat this injury with variable success rates. If not adequately treated, they may even lead to the development of early-onset osteoarthritis. Among all the available techniques, microfractures are used in restoring the cartilage tissue, especially in the deep and extended lesions.
More recently, the need for minor bone trauma with still adequate bleeding resulted in the development of nanofractures. Nanofracturing means creating perforations with a smaller diameter that go deeper into the bone while damaging it less. This is supposed to reduce the injury to the subchondral bone and increase the amount of bone marrow-derived mesenchymal stromal cells at the bone surface.
Thus, the aim of this pilot study is to evaluate the efficacy of nanofractures for the treatment of cartilage lesions of the knee, specifically focusing on the chondral healing that will be addressed with magnetic resonance imaging.
- Conditions
- Cartilage Damage
- Being tested
- Nanofracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanofractureProcedure or surgery
The planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee.
Nanofractures will be standardized 9 mm deep perforations in the subchondral bone.
Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Nanofracture | Experimental | The planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee.
Nanofractures will be standardized 9 mm deep perforations in the subchondral bone.
Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care. Receives: Procedure: Nanofracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes measured by International Knee Documentation Committee subjective score
The IKDC subjective score is a patient-completed tool to evaluate knee function. It contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 12 months
Secondary outcomes (5)
Functional outcomes measured by International Knee Documentation Committee subjective score
he IKDC subjective score is a patient-completed tool to evaluate knee function. It contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 6 months, 24 months
Activity level measured by Tegner score
Tegner activity score is a one-item questionnaire that can be used to evaluate pre-injury and current activity levels. It consists of 11 levels of grading activities (e.g., daily living, recreation, and competitive sports), with a score of zero representing "Sick leave or disability pension because of knee problems", 1 to 5 representing activities ranging from sedentary jobs to heavy manual labor, 6 to 9 representing recreational and competitive sports, and a score of 10 can be achieved by participating in national and international elite sports
Measured: 6 months, 12 months, 24 months
Knee pain on the Visual Analogic Scale
The pain Visual Analogic Scale records the patient's self-rated knee pain on a virtual visual analogue scale. It ranges from 0-10 where the endpoints are labelled 'No pain' and 'The worst pain you can imagine'. It can be used as a quantitative measure of pain outcome that reflects the patient's judgement
Measured: 6 months, 12 months, 24 months
Activity level measured by Knee injury and Osteoarthritis Outcome Score
The Knee injury and Osteoarthritis Outcome Score has been developed to assess 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.
Measured: 6 months, 12 months, 24 months
Cartilage Repair Tissue measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) 2.0 score
The MOCART 2.0 score is a classification system that consists in 9 variables which are used to describe the morphology and signal intensity of the repair tissue compared to the adjacent native cartilage. T the MOCART 2.0 score will be calculated at magnetic resonance imaging performed 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start2 Mar 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage DamageStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Deabate, MD, Principal investigator, Service of Orthopaedics and Traumatology, Department of Surgery, EOC, Lugano, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660161
- Sponsor's protocol ID
- ORL-ORT-037
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2022
- Last updated
- 9 Sep 2026
- Results posted
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Functional Outcome of Nanofractures for the Treatment of Cartilage Lesions
- ClinicalTrials.gov ID
- NCT05660161
- Acronym / sponsor ID
- ORL-ORT-037
- Conditions
- Cartilage Damage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Dec 2022 (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.
Articular cartilage lesions, with their inherent limited healing potential, remain a challenging problem for orthopaedic surgeons. Various techniques, both palliative and reparative, have been used to treat this injury with variable success rates. If not adequately treated, they may even lead to the development of early-onset osteoarthritis. Among all the available techniques, microfractures are used in restoring the cartilage tissue, especially in the deep and extended lesions.
More recently, the need for minor bone trauma with still adequate bleeding resulted in the development of nanofractures. Nanofracturing means creating perforations with a smaller diameter that go deeper into the bone while damaging it less. This is supposed to reduce the injury to the subchondral bone and increase the amount of bone marrow-derived mesenchymal stromal cells at the bone surface.
Thus, the aim of this pilot study is to evaluate the efficacy of nanofractures for the treatment of cartilage lesions of the knee, specifically focusing on the chondral healing that will be addressed with magnetic resonance imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanofracture | Experimental | Procedure: NanofractureThe planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee. Nanofractures will be standardized 9 mm deep perforations in the subchondral bone. Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with cartilage lesions of the knee scheduled for surgery
- Age 16-50
- BMI between 18.5 and 30 points
- Ability to give informed consent
Key exclusion criteria (5 listed)
- Uncorrected knee instability
- Meniscectomy > 50%
- Uncorrected knee misalignment
- Uncontrolled metabolic diseases
- Inability to give informed consent
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 |
|---|---|---|
| NanofractureThe planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee. Nanofractures will be standardized 9 mm deep perforations in the subchondral bone. Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care. | Procedure or surgery | Nanofracture |
Primary outcome
Functional outcomes measured by International Knee Documentation Committee subjective score
Time frame: 12 months
The IKDC subjective score is a patient-completed tool to evaluate knee function. It contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
5 secondary outcomes
Functional outcomes measured by International Knee Documentation Committee subjective score
Time frame: 6 months, 24 months
Activity level measured by Tegner score
Time frame: 6 months, 12 months, 24 months
Knee pain on the Visual Analogic Scale
Time frame: 6 months, 12 months, 24 months
Activity level measured by Knee injury and Osteoarthritis Outcome Score
Time frame: 6 months, 12 months, 24 months
Cartilage Repair Tissue measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) 2.0 score
Time frame: 12 months
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 9 Sep 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.
Luca Deabate, MD principal investigator
Service of Orthopaedics and Traumatology, Department of Surgery, EOC, Lugano, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanofracture in people with Cartilage Damage, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 Switzerland. 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 Alessandro Sangiorgio, MD (+41 091 811 7029, alessandro.sangiorgio@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcomes measured by International Knee Documentation Committee subjective score (time frame: 12 months). 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 9 Sep 2026.