Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01975467
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01975467
Study Brief:
Protocol Section:
NCT01975467