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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02383160
Eligibility Criteria:
Inclusion Criteria:
* Subject has a scaphoid fracture \> 3 months-old with at least one feature of non-union including, collapse or humpback deformity, sclerosis at the fracture site or cystic changes evident on pre-operative diagnostic imaging
* Subject has consented to surgical fixation at surgeon discretion
* Subject is willing and has the ability to operate the LIPUS device for at least four to six months post-operatively
Exclusion Criteria:
* Subject with concomitant fracture or dislocation of another ipsilateral carpal bone, distal radius or ulna, or bilateral scaphoid fractures
* Subject has an open or pathological fracture
* Subject who are actively receiving treatment of a rheumatologic disorder with a biologic medication or other arthritic condition
* Subject has a history of fibrous dysplasia, chronic renal failure, Paget's disease, osteopetrosis or other impairing disease/condition of the musculoskeletal system
* Subject with an active infection of the affected limb
* Subject with a high risk of death within the follow up period
* Subject is a prisoner or at high risk of incarceration
* Subject who are unlikely to complete follow-up (no fixed address, states they are unlikely to complete follow up, psychiatric condition at surgeon discretion)
* Subject has cognitive impairment or language difficulties that would impede the completion of questionnaires
* Subject who are pregnant or anticipate getting pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT02383160
Study Brief:
Protocol Section:
NCT02383160