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.
NCT ID: NCT05483387
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2022-11-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HBS 2 Resorb Mg
Study arm treated with the HBS 2 Resorb Mg.
Treatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Interventions
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Treatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Clinical Study Centers, LLC
OTHER
KLS Martin
INDUSTRY
Responsible Party
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Locations
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Centrum für Muskuloskeletale Chirurgie (CMSC)
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMCF-00007_PLAN_002
Identifier Type: -
Identifier Source: org_study_id
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