Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/13/2015 |
Start Date: | October 2013 |
End Date: | October 2014 |
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.
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.
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
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