Clinical Trials in the UK / NCT03312465
Active, not recruiting
Observational
Anatomical Shoulder Domelock System Study
NCT03312465 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Avascular NecrosisRevision SurgeryConditions Consequent to Earlier OperationsArthritis, RheumatoidArthritis, DegenerativeArthritis;Traumatic
Investigational drug(s) / intervention(s)
AS Domelock System
AS Domelock System: Hemi or Total Shoulder Arthroplasty
Study summary
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.
Eligibility
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)
Primary outcome measure(s)
- Implant Survivorship — 10 Years
The primary endpoint of this study is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | Belgium | |
| Krankenhaus Maria Hilf | Daun | Germany | |
| HELIOS ENDO-Klinik Hamburg | Hamburg | Germany | |
| Univeritätklinik Bagrist | Zurich | Canton of Zurich | |
| Universitätsspital Basel | Basel | Switzerland | |
| Royal Derby Hospital | Derby | United Kingdom |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03312465 on ClinicalTrials.gov ↗ ← All trials in the UK