Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment
Terminated
- Conditions
- Fracture of Clavicle
- Interventions
- Device: CRx
- Registration Number
- NCT01975467
- Lead Sponsor
- Sonoma Orthopedic Products, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Test Group - Intramedullary Nail CRx Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
- Primary Outcome Measures
Name Time Method DASH Score 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.
- Secondary Outcome Measures
Name Time Method Range of Motion and Strength One time point The ASES instrument will be used to assess range of motion and strength.
Trial Locations
- Locations (2)
North Coast Orthopaedics and Sports Medicine
🇺🇸Arcata, California, United States
Madison Center/Polyclinic
🇺🇸Seattle, Washington, United States