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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.

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.

Recruiting
18 years and older
All
Phase 4

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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.

Eligibility

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

Study details
    Intraarticular Fracture
    Extraarticular Fracture
    Pseudarthrosis
    Arthrosis

NCT05483387

KLS Martin

25 January 2024

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