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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
KLS Martin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraarticular Fracture focused on measuring small Bone, resorbable Implant, Magnesium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 28, 2022
Last Updated
March 7, 2023
Sponsor
KLS Martin
Collaborators
Clinical Study Centers, LLC
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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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