Knee cartilage repair study halted early – too few patients to draw conclusions

NCT ID NCT04184687

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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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