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 Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Intraarticular Fracture, Extraarticular Fracture, Pseudarthrosis, Arthrosis

Intervention / Treatment
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* Device: Treatment with HBS 2 Resorb Mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBS 2 Resorb Mg<br>Study arm treated with the HBS 2 Resorb Mg. | Device: Treatment with HBS 2 Resorb Mg<br>* Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bony Fusion (Change) | The primary endpoint of the study is the fusion rate of the bone. After the onset of bony fusion, the implant no longer fulfils any function, and it should be resorbed. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary displacement and breakage of the implant (YES/NO) | Any secondary radiographic displacement or breakage of the implant or any clinically significant loss of reduction is noted. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 
| Deep infection(YES/NO) | The presence of deep infections is assessed binary. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 
| Clinical outcome | Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 
| Surgical revisions(YES/NO) | As typically one single surgery should be sufficient to treat the patient, all secondary surgical interventions are revisions due to a complication. This includes also re-operation due to screw removal. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 
| Early corrosion phenomenon(YES/NO) | Symptomatic gas accumulation or formation of gas pockets due to degradation of the material. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 
| Radiolucency(YES/NO) | Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon. | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small Bone, resorbable Implant, Magnesium