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Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

NCT ID: NCT01975467

Last Updated: 2016-12-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fracture of Clavicle

Keywords

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midshaft clavicle fracture intramedullary nail sling

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control Group - Nonoperative

Subjects that were treated with a sling for their displaced midshaft clavicle fracture.

No interventions assigned to this group

Test Group - Intramedullary Nail

Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.

CRx

Intervention Type DEVICE

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

Interventions

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CRx

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

Intervention Type DEVICE

Other Intervention Names

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Intramedullary Nail

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonoma Orthopedic Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John LeBlanc, DO

Role: PRINCIPAL_INVESTIGATOR

North Coast Orthopaedics and Sports Medicine

Carl Basamania, MD

Role: PRINCIPAL_INVESTIGATOR

Madison Center/Polyclinic

Locations

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North Coast Orthopaedics and Sports Medicine

Arcata, California, United States

Site Status

Madison Center/Polyclinic

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CRx-001

Identifier Type: -

Identifier Source: org_study_id