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Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

NCT01975467 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2016-12-28

Study results available
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Summary

The objective of this post-market clinical study is to compare one to three year post treatment results, range of motion, strength, patient related functional outcomes and patient satisfaction, of internal fixation using the Sonoma Orthopedic Products CRx™ as compared to nonoperative management (e.g. sling) of similar displaced midshaft clavicle fractures.

Conditions

  • Fracture of Clavicle

Interventions

DEVICE

CRx

The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.

Sponsors & Collaborators

  • Sonoma Orthopedic Products, Inc.

    lead INDUSTRY

Principal Investigators

  • John LeBlanc, DO · North Coast Orthopaedics and Sports Medicine

  • Carl Basamania, MD · Madison Center/Polyclinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01975467 on ClinicalTrials.gov