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New Stem-Free shoulder implant shows promise in european study

NCT ID NCT01700543

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study followed 152 people who received the Sidus Stem-Free Shoulder implant for severe shoulder pain and disability due to arthritis or other joint diseases. The implant is designed to replace the shoulder joint without a long stem, potentially preserving more bone. Researchers measured pain, function, quality of life, and implant survival to confirm the device's safety and performance.

What this could mean

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

Active substance
Sidus Stem-Free Shoulder implant (a shoulder replacement device)
What this could lead to
If successful, this implant could provide a reliable option for shoulder replacement with less bone removal, potentially improving recovery and implant longevity.
What could go wrong
This is a post-market study, meaning the device is already on the market. It is not approved in the US, and results may not apply to all patients. Risks include implant failure, infection, or need for revision 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

152 people

The number who actually took part.

Started

Oct 2012

Finished

Mar 2026

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

Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.

Ages

18 to 80 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: * Patient is 18 to 80 years of age, inclusive. * The patient is skeletally mature. * Patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral HSA or TSA based on physical exam and medical history. * Patient has failed conservative treatment. * Patient meets at least one of the following indications: Osteoarthritis, Posttraumatic arthrosis, Rheumatoid arthritis without humeral metaphyseal defects, Focal avascular necrosis of the humeral head, Previous surgeries of the shoulder that do no compromise the fixation. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the Ethics Committee approved "Informed Consent". Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is an known drug abuser, a known alcoholic or anyone who cannot understand what is required of them. * Patient is known to be pregnant or breastfeeding. * Patient meets at least one of the contraindications: Soft or inadequate humeral bone (including osteoporosis and extensive avascular necrosis or rheumatoid arthritis) leading to poor implant fixation, Metaphyseal bony defect (including large cysts), Posttraumatic tuberosity non-union, Signs of infection, Irreparable cuff tear, Revision from a failed stemmed prosthesis, Charcot's shoulder (neuroarthropathy)

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Conditions

The condition(s) this trial relates to.

arthritic joint disease avascular necrosis osteoarthritis osteonecrosis rheumatoid arthritis

As listed by the trial registrant

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

Avascular necrosis Inflammatory joint disease (IJD) Non-inflammatory degenerative joint disease (nidjd) Osteoarthritis Rheumatoid arthritis

Contacts and locations

Locations

  • AKH Linz

    Linz, Austria

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Italy

  • Centre Hospitalier Universitaire Toulouse

    Toulouse, France

  • Charité

    Berlin, Germany

  • Gemeinschaftspraxis am Wall

    Rinteln, Germany

  • Groupe Chirurgical Thiers

    Grenoble, France

  • New Royal Infirmary of Edinburgh

    Edinburgh, United Kingdom

  • Orthopaedische Chirurgie Muenchen

    Munich, Germany

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