NCT05454306

Brief 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.

Trial Health

50
Monitor

Trial Health Score

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

Timeline
24mo left

Started Jan 2028

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
5.5 years until next milestone

Study Start

First participant enrolled

January 9, 2028

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2030

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

July 7, 2022

Last Update Submit

March 16, 2026

Conditions

Clavicle Fracture

Keywords

Clavicle fractureClavicle pin

Outcome Measures

Primary Outcomes (10)

  • ASES Score- 2 week

    American Shoulder and Elbow Surgeons Score

    2 weeks post-operation

  • ASES Score- 6 week

    American Shoulder and Elbow Surgeons Score

    6 weeks post-operation

  • ASES Score- 3 month

    American Shoulder and Elbow Surgeons Score

    3 months post-operation

  • ASES Score- 1 year

    American Shoulder and Elbow Surgeons Score

    1 year post-operation

  • DASH Score- 2 week

    Disabilities of Arm, Shoulder and Hand Score

    2 weeks post-operation

  • DASH Score- 6 week

    Disabilities of Arm, Shoulder and Hand Score

    6 weeks post-operation

  • DASH Score- 3 month

    Disabilities of Arm, Shoulder and Hand Score

    3 months post-operation

  • DASH Score- 1 year

    Disabilities of Arm, Shoulder and Hand Score

    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

    1 year post-operation

  • Clinical union rate

    Clinical union is defined as the absence of pain over the fracture site upon palpation.

    1 year post-operation

Study Arms (1)

Anser Clavicle Pin

EXPERIMENTAL

Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture

Device: Anser Clavicle Pin

Interventions

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.

Anser Clavicle Pin

Eligibility Criteria

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

You may qualify if:

  • Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification
  • Skeletally mature
  • Surgery performed within 4 weeks after trauma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Jonathan Braman, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 12, 2022

Study Start (Estimated)

January 9, 2028

Primary Completion (Estimated)

January 9, 2030

Study Completion (Estimated)

January 9, 2030

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

US(1)