Trials / Active Not Recruiting
Active Not RecruitingNCT03312465
Anatomical Shoulder Domelock System Study
Anatomical Shoulder™ Domelock System A Multicenter, Prospective and Retrospective, Non-Controlled Post-Market Clinical Follow-up Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 73 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AS Domelock System | Hemi or Total Shoulder Arthroplasty |
Timeline
- Start date
- 2017-09-28
- Primary completion
- 2032-12-09
- Completion
- 2032-12-09
- First posted
- 2017-10-17
- Last updated
- 2026-03-25
Locations
6 sites across 4 countries: Belgium, Germany, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03312465. Inclusion in this directory is not an endorsement.