NCT05483387

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

July 28, 2022

Last Update Submit

March 7, 2023

Conditions

Intraarticular FractureExtraarticular FracturePseudarthrosisArthrosis

Keywords

small Boneresorbable ImplantMagnesium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Secondary displacement and breakage of the implant (YES/NO)

    6 weeks, 12 weeks, 6 month and 12 month after surgery

  • Deep infection(YES/NO)

    6 weeks, 12 weeks, 6 month and 12 month after surgery

  • Clinical outcome

    6 weeks, 12 weeks, 6 month and 12 month after surgery

  • Surgical revisions(YES/NO)

    6 weeks, 12 weeks, 6 month and 12 month after surgery

  • Early corrosion phenomenon(YES/NO)

    6 weeks, 12 weeks, 6 month and 12 month after surgery

  • +1 more secondary outcomes

Study Arms (1)

HBS 2 Resorb Mg

EXPERIMENTAL

Study arm treated with the HBS 2 Resorb Mg.

Device: Treatment with HBS 2 Resorb Mg

Interventions

Treatment with HBS 2 Resorb MgDEVICE

Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments

HBS 2 Resorb Mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum für Muskuloskeletale Chirurgie (CMSC)

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Intra-Articular FracturesPseudarthrosisOsteoarthritis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesFractures, UnunitedArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Serafeim Tsitsilonis, PD Dr.

CONTACT

+49 30 450 652 127serafeim.tsitsilonis@charite.de

Heilwig Fischer, Dr.

CONTACT

+49 30 450 655049heilwig.fischer@charite.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 2, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

DE(1)