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Knee surgery showdown: button vs. screw for ACL graft fixation

NCT ID NCT02918734

Disease control Sponsor: St. Olavs Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial compares two methods for fixing a tendon graft during ACL knee surgery: a newer button system (Endobutton CL BTB) versus standard metal screws. About 220 people having their first ACL reconstruction will be randomly assigned to one method. The study tracks knee function, stability, strength, and bone healing over time to see which approach works better.

What this could mean

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

Active substance
a device for fixing a tendon graft in ACL reconstruction: either the Endobutton CL BTB system or a metal interference screw
What this could lead to
If the Endobutton proves better, it could become the preferred method for ACL graft fixation, potentially improving recovery and reducing complications.
What could go wrong
This is a single-center trial, and the newer method may not show clear advantages over the standard screw. Bone healing with the Endobutton is still unconfirmed.

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 220 people

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

Started

Oct 2016

Expected to finish

Mar 2033

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 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: * Primary reconstruction of ACL ruptures * Surgery at least 6 weeks after injury * The patient must accept and sign the informed consent form before surgery Exclusion Criteria: * Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling) * Previous major surgical procedures in the same knee * Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair) * Contralateral ACL injury (treated or untreated) * Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)

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Conditions

The condition(s) this trial relates to.

Knee Injuries

As listed by the trial registrant

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

Knee injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Orthopedic Surgery, St Olavs Hospital

    RECRUITING

    Trondheim, Norway

  • Rosenborgklinikken

    RECRUITING

    Trondheim, Norway

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