Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

November 1, 2016 updated by: Sonoma Orthopedic Products, Inc.

CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Arcata, California, United States, 95521
        • North Coast Orthopaedics and Sports Medicine
    • Washington
      • Seattle, Washington, United States, 98104
        • Madison Center/Polyclinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population is open to anyone over the age of 18 that meet the study eligibility criteria.

Description

Inclusion Criteria:

  • A displaced transverse or oblique midshaft clavicle fracture with or without comminution
  • Must be 12 ± 2 months to 36 ± 2 months post-treatment
  • Must have received nonoperative treatment or operative treatment with a CRx™ device, no other devices, for their clavicle fracture
  • Male or female at least 18 years of age
  • Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
  • Ability to understand and provide written authorization for use and disclosure of personal health information

Exclusion Criteria:

  • Open, or segmental clavicle fracture
  • Any clavicle or upper extremity fracture previous, concurrent, or subsequent to the study fracture
  • Removal of the CRx™ device within 8 weeks of the study visit
  • History of alcoholism
  • Currently on chemotherapy or radiation therapy
  • Habitual use of narcotic pain medications prior to injury or after injury for reasons other than clavicle pain
  • Currently on worker's compensation
  • History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
  • Rheumatoid arthritis or other inflammatory arthropathies.
  • History of chronic pain issues for reasons other than clavicle pain or psychiatric disorder that precludes reliable follow-up.
  • Women that are pregnant or think that they might be pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group - Nonoperative
Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
Test Group - Intramedullary Nail
Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
Device: CRx
The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
Other Names:
  • Intramedullary Nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH Score
Time Frame: One time point
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
One time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion and Strength
Time Frame: One time point
The ASES instrument will be used to assess range of motion and strength.
One time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonoma Orthopedic Products, Inc.

Investigators

  • Principal Investigator: John LeBlanc, DO, North Coast Orthopaedics and Sports Medicine
  • Principal Investigator: Carl Basamania, MD, Madison Center/Polyclinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRx-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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