Arthrosis, Extraarticular Fracture, Intraarticular Fracture, Pseudarthrosis
Conditions
Keywords
small Bone, resorbable Implant, Magnesium
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.
Interventions
DEVICETreatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Sponsors
Clinical Study Centers, LLC
KLS Martin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bony Fusion (Change) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep infection(YES/NO) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | The presence of deep infections is assessed binary. |
| Clinical outcome | 6 weeks, 12 weeks, 6 month and 12 month after surgery | Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction. |
| Secondary displacement and breakage of the implant (YES/NO) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | Any secondary radiographic displacement or breakage of the implant or any clinically significant loss of reduction is noted. |
| Early corrosion phenomenon(YES/NO) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | Symptomatic gas accumulation or formation of gas pockets due to degradation of the material. |
| Radiolucency(YES/NO) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon. |
| Surgical revisions(YES/NO) | 6 weeks, 12 weeks, 6 month and 12 month after surgery | 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. |
Countries
Germany
Contacts
Primary ContactSerafeim Tsitsilonis, PD Dr.
Backup ContactHeilwig Fischer, Dr.
Outcome results
None listed