Status:
ACTIVE_NOT_RECRUITING
Anatomical Shoulder Domelock System Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Avascular Necrosis
Revision Surgery
Eligibility:
All Genders
18-80 years
Brief 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, ...
Detailed Description
This study is a multicenter, prospective and retrospective, non-controlled PMCF study involving orthopaedic surgeons skilled in hemi and total shoulder arthroplasty procedures. A minimum of six study ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 9 2032
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03312465
Start Date
September 28 2017
End Date
December 9 2032
Last Update
June 15 2025
Active Locations (6)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
2
Krankenhaus Maria Hilf
Daun, Germany
3
HELIOS ENDO-Klinik Hamburg
Hamburg, Germany
4
Univeritätklinik Bagrist
Zurich, Canton of Zurich, Switzerland, 8008