Clinical trial NCT05483387: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intraarticular Fracture
Extraarticular Fracture
Pseudarthrosis
Arthrosis
Keywords: small Bone
resorbable Implant
Magnesium
Lead sponsor: KLS Martin
Sponsor class: INDUSTRY
Collaborators: name: Clinical Study Centers, LLC
First posted: 2022-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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

Primary outcomes:
measure: Bony Fusion (Change)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Secondary outcomes:
measure: Secondary displacement and breakage of the implant (YES/NO)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
measure: Deep infection(YES/NO)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
measure: Clinical outcome
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
measure: Surgical revisions(YES/NO)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
measure: Early corrosion phenomenon(YES/NO)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
measure: Radiolucency(YES/NO)
timeFrame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Centrum für Muskuloskeletale Chirurgie (CMSC)
Study officials:
References: