Clavicle FractureNCT05454306
Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
A study testing Anser Clavicle Pin in people with Clavicle Fracture, run by University of Minnesota at 1 site in United States.
Trial summary
The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Anser Clavicle Pin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2028to 9 Jan 2030
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
- Skeletally mature
- Surgery performed within 4 weeks after trauma
Who cannot join
- Not fit for surgery by the anesthesiologist
- Nonunion or previous malunion
- Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
- Additional neurovascular injury
- Pathologic fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series
The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.
- Conditions
- Clavicle Fracture
- Being tested
- Anser Clavicle Pin
- Keywords
- Clavicle fracture, Clavicle pin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anser Clavicle PinDevice
The Anser Clavicle Pin is an intramedullary device that has been studied in 20 patients in an EU-based prospective case series.28 A 100% union rate was found. The Constant-Murley score at 1-year was 96.7 (SD 5). The Disabilities of Arm, Shoulder and Hand score was 5.1 (SD 10). There were no infections, neuropathy of the supraclavicular nerve or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred including plastic deformation, protrusion and hardware failure. VAS satisfaction was 8.9 (SD 1) at the 1-year follow up.
| Study group | Role | What they receive |
|---|---|---|
| Anser Clavicle Pin | Experimental | Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture Receives: Device: Anser Clavicle Pin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES Score- 2 week
American Shoulder and Elbow Surgeons Score
Measured: 2 weeks post-operation
ASES Score- 6 week
American Shoulder and Elbow Surgeons Score
Measured: 6 weeks post-operation
ASES Score- 3 month
American Shoulder and Elbow Surgeons Score
Measured: 3 months post-operation
ASES Score- 1 year
American Shoulder and Elbow Surgeons Score
Measured: 1 year post-operation
DASH Score- 2 week
Disabilities of Arm, Shoulder and Hand Score
Measured: 2 weeks post-operation
DASH Score- 6 week
Disabilities of Arm, Shoulder and Hand Score
Measured: 6 weeks post-operation
DASH Score- 3 month
Disabilities of Arm, Shoulder and Hand Score
Measured: 3 months post-operation
DASH Score- 1 year
Disabilities of Arm, Shoulder and Hand Score
Measured: 1 year post-operation
Radiographic union rate
Radiographic union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist
Measured: 1 year post-operation
Clinical union rate
Clinical union is defined as the absence of pain over the fracture site upon palpation.
Measured: 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start9 Jan 2028 (estimated)
- Primary completion9 Jan 2030 (estimated)
- Study completion9 Jan 2030 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Braman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454306
- Sponsor's protocol ID
- ORSU-2022-31047
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series
- ClinicalTrials.gov ID
- NCT05454306
- Acronym / sponsor ID
- ORSU-2022-31047
- Conditions
- Clavicle Fracture
- Keywords
- Clavicle fracture, Clavicle pin
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Jan 2028 (estimated)
- Primary completion
- 9 Jan 2030 (estimated)
- Study completion
- 9 Jan 2030 (estimated)
- First posted
- 12 Jul 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.
The goals of this multi-site study are to evaluate the union rate, patient satisfaction, and functional results of the Section 510(K) approved Anser Clavicle Pin in a prospective 50 patient clinical trial in a U.S. population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anser Clavicle Pin | Experimental | Device: Anser Clavicle PinPatients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
- Skeletally mature
- Surgery performed within 4 weeks after trauma
Key exclusion criteria (5 listed)
- Not fit for surgery by the anesthesiologist
- Nonunion or previous malunion
- Possible noncompliant patients (eg, alcohol and drug addiction, dementia)
- Additional neurovascular injury
- Pathologic fractures
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 |
|---|---|---|
| Anser Clavicle PinThe Anser Clavicle Pin is an intramedullary device that has been studied in 20 patients in an EU-based prospective case series.28 A 100% union rate was found. The Constant-Murley score at 1-year was 96.7 (SD 5). The Disabilities of Arm, Shoulder and Hand score was 5.1 (SD 10). There were no infections, neuropathy of the supraclavicular nerve or hardware irritation requiring removal of hardware. Three device-related complications (15%) occurred including plastic deformation, protrusion and hardware failure. VAS satisfaction was 8.9 (SD 1) at the 1-year follow up. | Device | Anser Clavicle Pin |
Primary outcome
ASES Score- 2 week
Time frame: 2 weeks post-operation
American Shoulder and Elbow Surgeons Score
ASES Score- 6 week
Time frame: 6 weeks post-operation
American Shoulder and Elbow Surgeons Score
ASES Score- 3 month
Time frame: 3 months post-operation
American Shoulder and Elbow Surgeons Score
ASES Score- 1 year
Time frame: 1 year post-operation
American Shoulder and Elbow Surgeons Score
DASH Score- 2 week
Time frame: 2 weeks post-operation
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 6 week
Time frame: 6 weeks post-operation
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 3 month
Time frame: 3 months post-operation
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 1 year
Time frame: 1 year post-operation
Disabilities of Arm, Shoulder and Hand Score
Radiographic union rate
Time frame: 1 year post-operation
Radiographic union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist
Clinical union rate
Time frame: 1 year post-operation
Clinical union is defined as the absence of pain over the fracture site upon palpation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
Jonathan Braman, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anser Clavicle Pin in people with Clavicle Fracture, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Mar 2026. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES Score- 2 week (time frame: 2 weeks post-operation). The study lists 10 primary outcomes in all. 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 18 Mar 2026.