Avascular NecrosisNCT03312465
Anatomical Shoulder Domelock System Study
An observational study of Avascular Necrosis and Revision Surgery, run by Zimmer Biomet at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations
- What is being tested?
- AS Domelock System
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 28 Sep 2017to 9 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Switzerland2 sites
Universitätsspital Basel
Basel
Univeritätklinik Bagrist
Zurich, Canton of Zurich, 8008
About this study
Official title: Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
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.
Read the 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 centers will be involved and a total number of 73 implants will be included into the study.
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid, Arthritis, Degenerative, Arthritis;Traumatic
- Being tested
- AS Domelock System
- Keywords
- Total Shoulder Arthroplasty, Hemi Shoulder Arthroplasty
- Medical subject headings
- Osteonecrosis, Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS Domelock SystemDevice
Hemi or Total Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| AS Domelock System Subjects | Subjects that receive the Anatomical Shoulder Domelock System Receives: Device: AS Domelock System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
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.
Measured: 10 Years
Secondary outcomes (1)
Clinical Performance
The secondary endpoint is defined by the performance of the Anatomical Shoulder Domelock System at 5 years, which is assessed by the Constant and Murley score.
The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start28 Sep 2017
- Primary completion9 Dec 2032 (estimated)
- Study completion9 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312465
- Sponsor's protocol ID
- CME2014-07E
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2017
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT03312465
- Acronym / sponsor ID
- CME2014-07E
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid, Arthritis, Degenerative, Arthritis;Traumatic
- Keywords
- Total Shoulder Arthroplasty, Hemi Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 9 Dec 2032 (estimated)
- Study completion
- 9 Dec 2032 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 centers will be involved and a total number of 73 implants will be included into the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS Domelock System Subjects | – | Device: AS Domelock SystemSubjects that receive the Anatomical Shoulder Domelock System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS Domelock SystemHemi or Total Shoulder Arthroplasty | Device | AS Domelock System Subjects |
Primary outcome
Implant Survivorship
Time frame: 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.
1 secondary outcome
Clinical Performance
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Rohmer study director
Zimmer Biomet Clinical Operations
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis and Revision Surgery, run by Zimmer Biomet at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Switzerland, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Survivorship (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.