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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.

K

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

HBS 2 Resorb Mg
Experimental group
Description:
Study arm treated with the HBS 2 Resorb Mg.
Treatment:
Device: Treatment with HBS 2 Resorb Mg

Trial contacts and locations

1

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Central trial contact

Serafeim Tsitsilonis, PD Dr.; Heilwig Fischer, Dr.

Data sourced from clinicaltrials.gov

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