New shoulder implant tracked for 10 years in 73 patients
NCT ID NCT03312465
First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times
Summary
This study follows 73 people who received a shoulder replacement using the Anatomical Shoulder Domelock System. The goal is to see how well the device works and how safe it is over 10 years. Participants have conditions like arthritis or avascular necrosis and have not improved with other treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anatomical Shoulder Domelock System (a shoulder replacement device)
- What this could lead to
- If successful, this could confirm that the device is a safe and effective option for shoulder replacement, helping to reduce pain and improve function.
- What could go wrong
- This is a post-market study with no control group, so results may not prove the device is better than other options. Some patients may experience complications like implant failure 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
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73 people
The number who actually took part.
- Started
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Sep 2017
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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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 suffering from severe shoulder pain and disability indicated for implantation of the Anatomical Shoulder Domelock System in hemi or total shoulder arthroplasty and who meet all inclusion and none of the exclusion criteria.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 18-80 years of age, inclusive * 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: * Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate. * Avascular necrosis * Conditions consequent to earlier operations * Optional use in revision: in some medical conditions (e.g., early revision when adequate bone stock exists), the surgeon may opt to use primary implants in a revision procedure. Additional criteria for retrospective patients: * patient has been implanted with the Domelock system before site initiation visit. * information available must include at minimum demographic information, the operative report and details of the device implanted. 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 a 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: * Patient's physical conditions that would impair adequate implant support and/or prevent the use of an appropriately sized implant, e.g., previous surgery, insufficient quality or quantity of bone, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to endanger the success of the intervention e.g., absence of musculoligamentous supporting structures, joint neuropathy or other conditions that may lead to inadequate skeletal fixation * Signs of infection * Severe instability secondary to advanced loss of osteochondral structure * Charcot's shoulder (neuroarthropathy)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HELIOS ENDO-Klinik Hamburg
Hamburg, Germany
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Krankenhaus Maria Hilf
Daun, Germany
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Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
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Univeritätklinik Bagrist
Zurich, Canton of Zurich, 8008, Switzerland
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Universitaire Ziekenhuizen Leuven
Leuven, Belgium
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Universitätsspital Basel
Basel, Switzerland
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