| Registry | NCT05483387 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | KLS Martin (Industry); collaborators: Clinical Study Centers, LLC |
| Conditions | Intraarticular Fracture, Extraarticular Fracture, Pseudarthrosis, Arthrosis |
| Interventions | Treatment with HBS 2 Resorb Mg (Device) |
| Dates | start 2022-11-01, primary completion 2025-12-31 (estimated), completion 2026-01-31 (estimated), first posted 2022-08-02, last updated 2023-03-08 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Intraarticular Fracture All trials for Extraarticular Fracture All trials of Treatment with HBS 2 Resorb Mg
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HBS 2 Resorb Mg | Experimental | Device: Treatment with HBS 2 Resorb Mg | Study arm treated with the HBS 2 Resorb Mg. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Patient is 18 years and older * Patient is undergoing surgery with HBS 2 Resorb Mg * Written informed consent obtained for the treatment * Treatment of intra-articular and extra articular fractures and pseudarthroses of small bones and bone fragments as well as arthrodeses in the treatment of: * Scaphoid fractures and scaphoid pseudarthroses * Proximal radius head fractures * Fractures of the radial styloid process * Fractures of the ulnar styloid process * Metacarpal fractures * Metatarsal fractures Exclusion Criteria: * Any not medically managed severe systemic disease * Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * Pregnancy or women planning to conceive within the study period * Persons who are legally detained in an official institution * Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study * Skeletally immature * Intraoperative decision to use implants other than the device under investigation
| Facility | City | Country | Status |
|---|---|---|---|
| Centrum für Muskuloskeletale Chirurgie (CMSC) | Berlin | Germany | Recruiting |