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.
Primary Purpose
Intraarticular Fracture, Extraarticular Fracture, Pseudarthrosis
Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Treatment with HBS 2 Resorb Mg
Sponsored by
About this trial
This is an interventional treatment trial for Intraarticular Fracture focused on measuring small Bone, resorbable Implant, Magnesium
Eligibility 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
Sites / Locations
- Centrum für Muskuloskeletale Chirurgie (CMSC)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HBS 2 Resorb Mg
Arm Description
Study arm treated with the HBS 2 Resorb Mg.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Deep infection(YES/NO)
The presence of deep infections is assessed binary.
Clinical outcome
Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction.
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.
Early corrosion phenomenon(YES/NO)
Symptomatic gas accumulation or formation of gas pockets due to degradation of the material.
Radiolucency(YES/NO)
Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon.
Full Information
NCT ID
NCT05483387
First Posted
July 28, 2022
Last Updated
March 7, 2023
Sponsor
KLS Martin
Collaborators
Clinical Study Centers, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05483387
Brief 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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KLS Martin
Collaborators
Clinical Study Centers, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraarticular Fracture, Extraarticular Fracture, Pseudarthrosis, Arthrosis
Keywords
small Bone, resorbable Implant, Magnesium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HBS 2 Resorb Mg
Arm Type
Experimental
Arm Description
Study arm treated with the HBS 2 Resorb Mg.
Intervention Type
Device
Intervention Name(s)
Treatment with HBS 2 Resorb Mg
Intervention Description
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
Primary Outcome Measure Information:
Title
Bony Fusion (Change)
Description
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.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Secondary Outcome Measure Information:
Title
Secondary displacement and breakage of the implant (YES/NO)
Description
Any secondary radiographic displacement or breakage of the implant or any clinically significant loss of reduction is noted.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Title
Deep infection(YES/NO)
Description
The presence of deep infections is assessed binary.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Title
Clinical outcome
Description
Patient pain (VAS) and outcome measures (Patient Related Outcome Measure) will be noted in order to assess patient satisfaction.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Title
Surgical revisions(YES/NO)
Description
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.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Title
Early corrosion phenomenon(YES/NO)
Description
Symptomatic gas accumulation or formation of gas pockets due to degradation of the material.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
Title
Radiolucency(YES/NO)
Description
Any radiolucency on the postoperative X-rays are noted. Radiolucency will be assessed by the operating surgeon.
Time Frame
6 weeks, 12 weeks, 6 month and 12 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serafeim Tsitsilonis, PD Dr.
Phone
+49 30 450 652 127
Email
serafeim.tsitsilonis@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Heilwig Fischer, Dr.
Phone
+49 30 450 655049
Email
heilwig.fischer@charite.de
Facility Information:
Facility Name
Centrum für Muskuloskeletale Chirurgie (CMSC)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafeim Tsitsilonis, PD Dr.
Phone
+49 30 450 652 127
Email
serafeim.tsitsilonis@charite.de
First Name & Middle Initial & Last Name & Degree
Heilwig Fischer, Dr.
Phone
+49 30 450 655049
Email
heilwig.fischer@charite.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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.
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