Clinical trial NCT01975467: Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Official title: CLAVICLE FRACTURE OUTCOMES: 1-3 YEAR FOLLOW UP OF DISPLACED MIDSHAFT FRACTURES TREATED WITH INTRAMEDULARY NAIL vs. NONOPERATIVE TREATMENT
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fracture of Clavicle
Keywords: midshaft clavicle fracture
intramedullary nail
sling
Lead sponsor: Sonoma Orthopedic Products, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is open to anyone over the age of 18 that meet the study eligibility criteria.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: DASH Score
timeFrame: One time point
Secondary outcomes:
measure: Range of Motion and Strength
timeFrame: One time point
Other outcomes:
Locations:
city: Arcata
country: United States
facility: North Coast Orthopaedics and Sports Medicine
state: California
city: Seattle
country: United States
facility: Madison Center/Polyclinic
state: Washington
Study officials:
affiliation: North Coast Orthopaedics and Sports Medicine
name: John LeBlanc, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Madison Center/Polyclinic
name: Carl Basamania, MD
role: PRINCIPAL_INVESTIGATOR
References: