Intraarticular FracturePhase 4NCT05483387
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.
A Phase 4 study testing Treatment with HBS 2 Resorb Mg in people with Intraarticular Fracture and Extraarticular Fracture, run by KLS Martin at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraarticular Fracture, Extraarticular Fracture, Pseudarthrosis
- What is being tested?
- Treatment with HBS 2 Resorb Mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2022to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Fractures of the radial styloid process
- Fractures of the ulnar styloid process
- Metacarpal fractures
- Metatarsal fractures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Centrum für Muskuloskeletale Chirurgie (CMSC)
Berlin, 13353
Serafeim Tsitsilonis, PD Dr., +49 30 450 652 127, serafeim.tsitsilonis@charite.de
Heilwig Fischer, Dr., +49 30 450 655049, heilwig.fischer@charite.de
About this study
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.
- Being tested
- Treatment with HBS 2 Resorb Mg
- Keywords
- small Bone, resorbable Implant, Magnesium
- Medical subject headings
- Intra-Articular Fractures, Pseudarthrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with HBS 2 Resorb MgDevice
Treatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments
| Study group | Role | What they receive |
|---|---|---|
| HBS 2 Resorb Mg | Experimental | Study arm treated with the HBS 2 Resorb Mg. Receives: Device: Treatment with HBS 2 Resorb Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Secondary outcomes (6)
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.
Measured: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Deep infection(YES/NO)
The presence of deep infections is assessed binary.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraarticular FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLS Martin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Study Centers, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483387
- Sponsor's protocol ID
- PMCF-00007_PLAN_002
- Status last verified
- Mar 2023
- First submitted
- 28 Jul 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05483387
- Acronym / sponsor ID
- PMCF-00007_PLAN_002
- Keywords
- small Bone, resorbable Implant, Magnesium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KLS MartinIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Study Centers, LLC
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBS 2 Resorb Mg | Experimental | Device: Treatment with HBS 2 Resorb MgStudy arm treated with the HBS 2 Resorb Mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with HBS 2 Resorb MgTreatment of fractures, arthrodesis or pseudarthroses of small bones and bone fragments | Device | HBS 2 Resorb Mg |
Primary outcome
Bony Fusion (Change)
Time frame: 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.
6 secondary outcomes
Secondary displacement and breakage of the implant (YES/NO)
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Deep infection(YES/NO)
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Clinical outcome
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Surgical revisions(YES/NO)
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Early corrosion phenomenon(YES/NO)
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Radiolucency(YES/NO)
Time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment with HBS 2 Resorb Mg in people with Intraarticular Fracture and Extraarticular Fracture, run by KLS Martin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serafeim Tsitsilonis, PD Dr. (+49 30 450 652 127, serafeim.tsitsilonis@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bony Fusion (Change) (time frame: 6 weeks, 12 weeks, 6 month and 12 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.