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 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.

Study Overview

• Status: Recruiting
• Conditions: Arthrosis; Pseudarthrosis; Intraarticular Fracture; Extraarticular Fracture
• Intervention / Treatment: Device: Treatment with HBS 2 Resorb Mg

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Serafeim Tsitsilonis, PD Dr.; Phone Number: +49 30 450 652 127; Email: serafeim.tsitsilonis@charite.de
• Study Contact Backup: Name: Heilwig Fischer, Dr.; Phone Number: +49 30 450 655049; Email: heilwig.fischer@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Centrum für Muskuloskeletale Chirurgie (CMSC)
    • Contact: Serafeim Tsitsilonis, PD Dr.; Phone Number: +49 30 450 652 127; Email: serafeim.tsitsilonis@charite.de
    • Contact: Heilwig Fischer, Dr.; Phone Number: +49 30 450 655049; Email: heilwig.fischer@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KLS Martin
• Collaborators: Clinical Study Centers, LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): January 31, 2026

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Magnesium; small Bone; resorbable Implant
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Fractures, Ununited; Osteoarthritis; Fractures, Bone; Intra-Articular Fractures; Pseudarthrosis
• Other Study ID Numbers: PMCF-00007_PLAN_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No