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Bone scaffold may help ACL grafts heal stronger

NCT ID NCT03462823

Disease control Sponsor: Sandro Fucentese Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether adding a special bone-like scaffold to the standard hamstring tendon graft improves healing after ACL reconstruction. The scaffold is designed to help the graft bond better with the bone and reduce bone tunnel widening. About 56 people with a recent ACL tear will be randomly assigned to receive either the scaffold-enhanced graft or the standard graft alone. The main goal is to see if the scaffold leads to better bone tunnel healing on CT scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
osteoconductive scaffold (bone substitute material)
What this could lead to
If successful, this scaffold could help ACL grafts heal more firmly into the bone, potentially reducing tunnel widening and improving long-term knee stability.
What could go wrong
This is a small, early-stage trial with 56 participants. The scaffold is new and may not improve outcomes over standard surgery, and there is a risk of infection or poor healing.

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

56 people

The number who actually took part.

Started

Apr 2017

Finished

Apr 2025

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 60 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 * Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the * Informed consent as documented by signature Exclusion Criteria: * Prior ACL reconstruction or other surgical procedure on the affected knee. * Prior fracture of the affected leg. * Multi-ligament reconstruction. * Previous or current ACL injury on contra-lateral leg. * Medical condition or comorbidity that would interfere with study participation. * The patient is mentally compromised. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.).

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Conditions

The condition(s) this trial relates to.

Anterior Cruciate Ligament Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACL Acl - anterior cruciate ligament rupture Acl injury

Contacts and locations

Locations

  • Balgrist University Hospital

    Zurich, 8008, Switzerland

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