Anatomical Shoulder Domelock System Study

NCT ID: NCT03312465

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 73 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2032-12-09

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, 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.

Conditions

Avascular Necrosis; Revision Surgery; Conditions Consequent to Earlier Operations; Arthritis, Rheumatoid; Arthritis, Degenerative; Arthritis;Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

AS Domelock System Subjects

Subjects that receive the Anatomical Shoulder Domelock System

AS Domelock System

Intervention Type: DEVICE

Hemi or Total Shoulder Arthroplasty

Interventions

AS Domelock System

Hemi or Total Shoulder Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Rohmer

Role: STUDY_DIRECTOR

Zimmer Biomet Clinical Operations

Locations

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Krankenhaus Maria Hilf

Daun, , Germany

HELIOS ENDO-Klinik Hamburg

Hamburg, , Germany

Univeritätklinik Bagrist

Zurich, Canton of Zurich, Switzerland

Universitätsspital Basel

Basel, , Switzerland

Royal Derby Hospital

Derby, , United Kingdom

Countries

Belgium; Germany; Switzerland; United Kingdom

Other Identifiers

CME2014-07E

Identifier Type: -

Identifier Source: org_study_id