Fracture of Clavicle
Conditions
Keywords
midshaft clavicle fracture, intramedullary nail, sling
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.
Interventions
DEVICECRx
The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
Sponsors
Sonoma Orthopedic Products, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion and Strength | One time point | The ASES instrument will be used to assess range of motion and strength. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group - Nonoperative Subjects that were treated with a sling for their displaced midshaft clavicle fracture. | 0 |
| Test Group - Intramedullary Nail Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.
CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Gender Female | 0 |
| Gender Male | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
DASH Score
Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.
Time frame: One time point
Population: Terminated due to low enrollment
Secondary
Range of Motion and Strength
The ASES instrument will be used to assess range of motion and strength.
Time frame: One time point