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.

Arthrosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05483387
• Other study ID #: PMCF-00007_PLAN_002
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2023
• Source: KLS Martin
• Contact: Serafeim Tsitsilonis, PD Dr.
• Phone: +49 30 450 652 127
• Email: serafeim.tsitsilonis[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrosis
• Fractures, Bone
• Intra-Articular Fractures
• Osteoarthritis
• Pseudarthrosis

Intervention

Device:
• Treatment with HBS 2 Resorb Mg
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments

Locations

Country	Name	City	State
Germany	Centrum für Muskuloskeletale Chirurgie (CMSC)	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
KLS Martin	Clinical Study Centers, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Deep infection(YES/NO)	The presence of deep infections is assessed binary.	6 weeks, 12 weeks, 6 month and 12 month after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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