Knee cartilage repair study halted early – too few patients to draw conclusions
NCT ID NCT04184687
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if a procedure called nanofractures could help repair cartilage damage in the knee at the same time as ACL reconstruction. Only 4 people took part before the study was stopped early. Because of the very small number of participants, no meaningful conclusions can be drawn about whether nanofractures are helpful or not.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nanofractures (a surgical procedure to stimulate cartilage repair)
- What this could lead to
- If successful, this approach could improve knee function and cartilage healing after ACL surgery.
- What could go wrong
- The study was terminated early with only 4 participants, so results are very limited and not reliable. It is unclear if nanofractures offer any benefit over standard ACL reconstruction alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
4 people
The number who actually took part.
- Started
-
Jul 2019
- Finished
-
Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients, 18 \< age \< 55; 2. Patients with complete ACL injury candidates for surgical reconstruction of the same; 3. Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively; 4. Patients without evidence of osteoarthritis 5. Patients' ability and consent to participate in clinical and radiological follow-up; 6. Signature of informed consent. Exclusion Criteria: 1. Patients incapable of understanding and of wanting; 2. State of immunodepression; 3. Patients with malignant neoplasms; 4. Patients suffering from rheumatic diseases; 5. Patients suffering from non-compensated diabetes; 6. Patients suffering from uncompensated thyroid metabolic disorders; 7. Patients abusing alcoholic beverages, drugs or drugs; 8. Patients with axial deviations\> 5 °; 9. Body Mass Index\> 35; 10. Patients treated with surgery at the same knee in the previous 12 months. 11. Cartilaginous lesions grade I-II according to the ICRS score. 12. Cartilage lesions with a diameter greater than 3 cm². 13. Non-suturable meniscal lesions requiring meniscectomy\> 50% and patients with previous meniscectomies\> 50% in the same compartment. 14. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Istituto Ortopedico Rizzoli
Bologna, Italy
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Other studies related to the condition(s) this trial covers.
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- Cartilage repair registry halted: what we can learn from early data