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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03312465




Registration number
NCT03312465
Ethics application status
Date submitted
12/10/2017
Date registered
17/10/2017
Date last updated
1/10/2024

Titles & IDs
Public title
Anatomical Shoulder Domelock System Study
Scientific title
Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
Secondary ID [1] 0 0
CME2014-07E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Avascular Necrosis 0 0
Revision Surgery 0 0
Conditions Consequent to Earlier Operations 0 0
Arthritis, Rheumatoid 0 0
Arthritis, Degenerative 0 0
Arthritis;Traumatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - AS Domelock System

AS Domelock System Subjects - Subjects that receive the Anatomical Shoulder Domelock System


Treatment: Devices: AS Domelock System
Hemi or Total Shoulder Arthroplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Survivorship
Timepoint [1] 0 0
10 Years
Secondary outcome [1] 0 0
Clinical Performance
Timepoint [1] 0 0
5 Years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2033
Actual
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Germany
State/province [2] 0 0
Daun
Country [3] 0 0
Germany
State/province [3] 0 0
Hamburg
Country [4] 0 0
Switzerland
State/province [4] 0 0
Basel
Country [5] 0 0
Switzerland
State/province [5] 0 0
Zürich
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Derby

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hassan Achakri
Address 0 0
Clinical Operations Director Zimmer Biomet EMEA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03312465