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.

Sponsor

KLS Martin (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05483387

Collaborator

Clinical Study Centers, LLC (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraarticular Fracture Extraarticular Fracture Pseudarthrosis Arthrosis	Device: Treatment with HBS 2 Resorb Mg	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jan 31, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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