WithdrawnNot Applicable

Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures

Stopped: funding

United States0Started 2028-01-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

ASES Score- 2 week

Timeframe: 2 weeks post-operation

ASES Score- 6 week

Timeframe: 6 weeks post-operation

ASES Score- 3 month

Timeframe: 3 months post-operation

ASES Score- 1 year

Timeframe: 1 year post-operation

DASH Score- 2 week

Timeframe: 2 weeks post-operation

DASH Score- 6 week

Timeframe: 6 weeks post-operation

DASH Score- 3 month

Timeframe: 3 months post-operation

DASH Score- 1 year

Timeframe: 1 year post-operation

Radiographic union rate

Timeframe: 1 year post-operation

Trial details

NCT IDNCT05454306

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01-09

View on ClinicalTrials.gov More Clavicle Fracture trials