Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

Study Overview
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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.

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

Conditions
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Fracture of Clavicle

Intervention / Treatment
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* Device: CRx


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group - Nonoperative<br>Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | |
| Test Group - Intramedullary Nail<br>Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. | Device: CRx<br>* The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.<br>* Other names: Intramedullary Nail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASH Score | 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 | The ASES instrument will be used to assess range of motion and strength. | One time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midshaft clavicle fracture, intramedullary nail, sling