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.

KLS Martin60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraarticular Fracture Extraarticular Fracture Pseudarthrosis Arthrosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bony Fusion (Change)

The primary endpoint of the study is the fusion rate of the bone. After the onset of bony fusion, the implant no longer fulfils any function, and it should be resorbed.