Evaluation of HBS 2 Resorb Mg screws for treating small bone fractures and pseudarthroses
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.
This study is testing if special magnesium screws can help people heal better after surgery for small bone fractures and related issues.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KLS Martin Industry-sponsored |
| Locations | 1 site (Berlin) |
| Trial ID | NCT05483387 on ClinicalTrials.gov |
What this trial studies
This multi-centre, prospective clinical observational study aims to assess the effectiveness of HBS 2 Resorb Mg screws in patients undergoing surgery for intra- and extraarticular fractures, pseudarthroses, and arthrodesis of small bones. The study will collect standard of care measurements to evaluate the device's performance under routine conditions. Participants will be monitored post-surgery to gather data on healing and outcomes associated with the use of these resorbable implants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing surgery involving HBS 2 Resorb Mg screws for specific small bone fractures.
Not a fit: Patients with severe systemic diseases, recent substance abuse issues, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing outcomes for patients with small bone fractures and related conditions.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using resorbable implants have shown promise in improving healing outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin
- Centrum für Muskuloskeletale Chirurgie (CMSC) — Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Serafeim Tsitsilonis, PD Dr.
- Email: serafeim.tsitsilonis@charite.de
- Phone: +49 30 450 652 127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.