Trials / Recruiting
RecruitingNCT06788717
MDR - Comprehensive Primary Revision Stems PMCF
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 59 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
Detailed description
The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Comprehensive Primary Revision Stems | Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty. |
Timeline
- Start date
- 2025-06-19
- Primary completion
- 2035-07-01
- Completion
- 2040-12-01
- First posted
- 2025-01-23
- Last updated
- 2025-07-11
Locations
2 sites across 2 countries: United States, Denmark
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06788717. Inclusion in this directory is not an endorsement.