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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT00196560
Eligibility Criteria:
Inclusion Criteria:
* skeletally mature patients less than 30 years of age
* sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint
* willing to participate in follow-up for at least two years
Exclusion Criteria:
* incompetent or unwilling to consent
* inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments
* previous instability of the affected shoulder
* significant associated fracture (exception Hill Sachs or Bankart lesions)
* concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program
* a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder
* neurovascular compromise of the affected limb
* a medical condition making the patient unable to wear a brace or sling
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
30 Years
Study:
NCT00196560
Study Brief:
Protocol Section:
NCT00196560