Prospective Post-market Clinical Follow-up Study of the HBS 2 Resorb Mg in Patients With Intra- and Extraarticular Fractures, Pseudarthroses and Arthrodesis of Small Bones and Bone Fragments.
NCT05483387 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-03-08
Summary
This study is a multi-centre, prospective, clinical observational study to evaluate the CE-marked HBS 2 Resorb Mg screws under routine conditions. The device will be used according to its intended use. The data collected for this study does only include measurements which are standard of care.
Conditions
- Intraarticular Fracture
- Extraarticular Fracture
- Pseudarthrosis
- Arthrosis
Interventions
- DEVICE
-
Treatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Sponsors & Collaborators
-
Clinical Study Centers, LLC
collaborator OTHER -
KLS Martin
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2025-12-31
- Completion
- 2026-01-31
Countries
- Germany
Study Locations
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