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New ACL graft shows promise in tiny trial

NCT ID NCT06091488

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new material called OrthoPure XT for repairing torn anterior cruciate ligaments (ACL) in the knee. Ten patients received the graft and were followed with questionnaires and MRI scans to assess knee function, pain, and healing. The goal was to see if OrthoPure XT is a safe and effective option when other graft types cannot be used.

What this could mean

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

Active substance
OrthoPure XT (a graft material for knee ligament reconstruction)
What this could lead to
If successful, OrthoPure XT could offer a reliable option for ACL reconstruction when other graft sources are not suitable.
What could go wrong
This was a very small study (10 people) with no comparison group, so results may not apply broadly. Long-term safety and effectiveness are not yet established.

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

10 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 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 65 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: * Patients between the ages of 18 and 65 at the time of ACL reconstruction surgery; * Patients aged 35 to 65 at the time of primary ACL reconstruction surgery; * Male and female sex; * First injury of the ACL with impossibility of use of autograft (patellar tendinopathy, quadriceps tendinopathy, goose leg tendinopathy) or refusal to use allograft (Bank tendon); * Recurrence of ACL injury with impossibility of use of autograft (prior use/tendinopathy of the patellar, previous use/tendinopathy of the quadriceps, previous use/tendinopathy of the goose leg) or refusal to use allograft (tendon of Bank); Exclusion Criteria: * Patients who do not consent to be included in the study * Presence of haematological, rheumatic or haemorrhagic disease time of assessment * ACL primary reconstruction in subjects under 35 * Allergies and/or reactions from hypersensitivity or religious objection to the use of porcine derivation * Pregnant and/or breastfeeding women

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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 injury

Contacts and locations

Locations

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.