Trials / Active Not Recruiting
Active Not RecruitingNCT04002518
MDR - Biomet Cannulated Screws
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) - A Retrospective/Prospective Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 51 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
Detailed description
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU). Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified. Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws. | Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw. |
Timeline
- Start date
- 2019-08-07
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2019-06-28
- Last updated
- 2025-10-30
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04002518. Inclusion in this directory is not an endorsement.