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Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

Primary Purpose

Clavicle Fracture

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anser Clavicle Pin
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture focused on measuring Clavicle fracture, Clavicle pin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anser Clavicle Pin

Arm Description

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

Outcomes

Primary Outcome Measures

ASES Score- 2 week
American Shoulder and Elbow Surgeons Score
ASES Score- 6 week
American Shoulder and Elbow Surgeons Score
ASES Score- 3 month
American Shoulder and Elbow Surgeons Score
ASES Score- 1 year
American Shoulder and Elbow Surgeons Score
DASH Score- 2 week
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 6 week
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 3 month
Disabilities of Arm, Shoulder and Hand Score
DASH Score- 1 year
Disabilities of Arm, Shoulder and Hand Score
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
Clinical union rate
Clinical union is defined as the absence of pain over the fracture site upon palpation.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2022
Last Updated
February 15, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05454306
Brief Title
Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures
Official Title
The Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures; A U.S. Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
funding
Study Start Date
January 9, 2024 (Anticipated)
Primary Completion Date
January 9, 2026 (Anticipated)
Study Completion Date
January 9, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture
Keywords
Clavicle fracture, Clavicle pin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anser Clavicle Pin
Arm Type
Experimental
Arm Description
Patients treated with Anser Clavicle Pin in the setting of a displaced midshaft clavicle fracture
Intervention Type
Device
Intervention Name(s)
Anser Clavicle Pin
Intervention Description
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.
Primary Outcome Measure Information:
Title
ASES Score- 2 week
Description
American Shoulder and Elbow Surgeons Score
Time Frame
2 weeks post-operation
Title
ASES Score- 6 week
Description
American Shoulder and Elbow Surgeons Score
Time Frame
6 weeks post-operation
Title
ASES Score- 3 month
Description
American Shoulder and Elbow Surgeons Score
Time Frame
3 months post-operation
Title
ASES Score- 1 year
Description
American Shoulder and Elbow Surgeons Score
Time Frame
1 year post-operation
Title
DASH Score- 2 week
Description
Disabilities of Arm, Shoulder and Hand Score
Time Frame
2 weeks post-operation
Title
DASH Score- 6 week
Description
Disabilities of Arm, Shoulder and Hand Score
Time Frame
6 weeks post-operation
Title
DASH Score- 3 month
Description
Disabilities of Arm, Shoulder and Hand Score
Time Frame
3 months post-operation
Title
DASH Score- 1 year
Description
Disabilities of Arm, Shoulder and Hand Score
Time Frame
1 year post-operation
Title
Radiographic union rate
Description
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
Time Frame
1 year post-operation
Title
Clinical union rate
Description
Clinical union is defined as the absence of pain over the fracture site upon palpation.
Time Frame
1 year post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Displaced midshaft clavicle fracture Type 2B according to the Robinson Classification Skeletally mature Surgery performed within 4 weeks after trauma Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Braman, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

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