Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury

Acumed

Status: Terminated

Conditions: Acute Scapholunate Injury

Treatments: Device: Acumed Scapholunate Intercarpal Screw

Study type: Observational

Funder types: Industry

Identifiers

NCT02579694

14013

Details and patient eligibility

About

The purpose of this retrospective-prospective clinical evaluation is to determine whether the SLIC Screw System provides provisional fixation to allow biological healing of the scapholunate interval.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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