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Metal or suture? the fixation choice that could spare a second knee operation

NCT ID NCT07819929

Disease control Sponsor: Stefano Zaffagnini Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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)

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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
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First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two ways of securing the graft during anterior cruciate ligament (ACL) reconstruction using the Over-The-Top technique. One group receives traditional metal staples, which hold well but can cause discomfort and sometimes need removal. The other group receives suture anchors, a metal-free option designed to hold the graft without prominent hardware. The trial follows adults aged 18 to 50 with an isolated ACL injury, measuring knee stability with KT-1000 and KiRA devices, along with failure rates, reoperations, and complications.

What this could mean

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

Active substance
ACL reconstruction using the Over-The-Top technique, with graft fixation by metal staples or suture anchors
What this could lead to
If suture anchors prove as stable as metal staples, surgeons could avoid a second operation to remove painful hardware and leave less metal in the knee.
What could go wrong
The trial is small and looks at one surgical technique at a single center, so its results may not apply to other surgeons or graft types. Fixation choice is only one of many factors that determine whether an ACL reconstruction succeeds.

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

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

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 50 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. Patients of either sex, aged between 18 and 50 years at the time of surgery; 2. Patients with an isolated anterior cruciate ligament (ACL) injury, with or without associated meniscal lesions, scheduled for ACL reconstruction and meniscal treatment; .3 Patients whose contralateral knee has never undergone meniscectomy, ligament reconstruction, unicompartmental knee arthroplasty, or total knee arthroplasty; 4\. Patients who have signed the informed consent form. Exclusion Criteria: 1. Patients with associated injury of the medial collateral ligament (MCL), lateral collateral ligament (LCL), posterolateral corner (PLC), or posterior cruciate ligament (PCL); 2. Patients with complete meniscal root tears, complete radial tears, or lateral meniscus oblique tears (LMORT); 3. Patients who underwent total or subtotal medial or lateral meniscectomy; 4. Patients with grade III-IV chondral lesions according to the Outerbridge classification identified at the time of surgery; 5. Patients who are unable to provide informed consent or who are unwilling to provide informed consent; 6. Patients with insufficient and/or compromised bone quality or quantity due to disease, infection, or previous implantation, such that adequate support and/or fixation of the devices cannot be ensured; 7. Patients with limited blood supply or a history of infections that could delay healing; 8. Patients with sensitivity to foreign materials.

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As listed by the trial registrant

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

Acl reconstruction Fixation

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • IRCCS Rizzoli Orthopedic Institute

    Bologna, 40136, Italy

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