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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT02579694
Eligibility Criteria:
Inclusion Criteria:
* Subjects willing and able to comprehend and sign Informed Consent
* Subjects who have received the SLIC screw as part of the treatment for scapholunate ligament repair or scapholunate reduction
* Subjects with acute scapholunate injury, classified with Garcia-Elias Stage 1-4, OR Geissler Stage 1-3
* Subjects \>18 years of age at the time of surgery
Exclusion Criteria:
* Subject diagnosed with chronic scapholunate injury
* Subjects who underwent previous scapholunate procedure on the study wrist before implantation of the SLIC Screw System
* Subjects with active or latent infection at the time of surgery
* Subjects with sepsis at the time of surgery
* Subjects diagnosed with osteoporosis at the time of surgery
* Subjects with insufficient quantity and/or quality of bone
* Subjects with cartilage degeneration on the bones at the time of surgery
* Subjects with absence of potential for soft tissue healing at time of surgery, as documented by the investigator.
* Female Subjects known to be pregnant
* Subjects who were unable to follow postoperative care instructions, specifically, activity levels
* Subjects who are unable or unwilling to return for postoperative study visits
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02579694
Study Brief:
Protocol Section:
NCT02579694