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 Martin

Status and phase

Enrolling

Phase 4

Conditions

Extraarticular Fracture

Pseudarthrosis

Intraarticular Fracture

Arthrosis

Treatments

Device: Treatment with HBS 2 Resorb Mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05483387

PMCF-00007_PLAN_002

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

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