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New shoulder button system tested for Long-Term safety

NCT ID NCT05397210

Disease control Sponsor: Xiros Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 58 people who have a dislocated shoulder joint (acromioclavicular joint) to see how well a medical device called the Infinity-Lock Button System works over time. The device is used to stabilise the joint after injury. Researchers will measure shoulder function and any side effects for up to 3 years after surgery.

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.

Participants

About 58 people

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

Started

Sep 2022

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Grade III-VI ACJ Dislocations.

Ages

16 years and older

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: * Patient must be 16 years old or above. * Patient is diagnosed with acute or chronic Grade Ill-VI ACJ dislocation. * Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC). Exclusion criteria. * Known hypersensitivity to implant materials. If the patient is suspected of having any foreign body sensitivity, appropriate tests should be made prior to implantation. * Infections or any other structural or pathological condition of the bone or soft tissue (such as hyperlaxity) that would be expected to impair healing or secure fixation. * Patients unable or unwilling to restrict activities to prescribed levels or follow a rehabilitation programme during the healing period. * Skeletally immature patients are not suited as the Infinity-Lock™ Button System will not elongate with growth. The use of this medical device and placement of hardware or implants must not bridge, disturb or disrupt the growth plate. * Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.

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Conditions

The condition(s) this trial relates to.

Joint Dislocations

As listed by the trial registrant

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

Acromioclavicular; dislocation

How to take part

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

  1. The places running it

    3 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 and phone numbers. 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

  • Barts Health NHS Trust

    RECRUITING

    London, E1 1FR, United Kingdom

  • East Kent Hospitals University NHS Foundation Trust,

    RECRUITING

    Canterbury, United Kingdom

  • Nottingham University Hospitals

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Royal Berkshire NHS Foundation Trust

    ACTIVE_NOT_RECRUITING

    Reading, RG1 5AN, United Kingdom

More trials for these conditions

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