Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury

Terminated

• Conditions: Acute Scapholunate Injury

• Registration Number: NCT02579694
• Lead Sponsor: Acumed, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-16
• Study First Posted: 2015-10-20
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of reported VAS pain from preoperative to post-planned explantation	12 months	Planned removal of provisional device recommended between six and 9 months; 12-month analysis will capture time to planned removal.
Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device	12 months
The proportion of devices where removal is attributed to healing and not device failure	12 months

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation of device integrity	12 months	Device integrity defined as no device breakage or separation
Radiographic evaluation of radiolucency	12 months
Radiographic evaluation of osteolysis	12 months
Complication rates over time	12 months
Comparison of range of motion in degrees from preoperative values	12 months	Flexion, Extension, Radial Deviation, Ulnar Deviation
Comparison of grip strength in kg from preoperative values	12 months
Comparison of reported VAS pain from preoperative values	12 months
Subject satisfaction based on a five-point scale from preoperative	12 months
Comparison of scapholunate angle from preoperative through radiographic evaluation	12 months
Comparison of scapholunate joint space from preoperative through radiographic evaluation	12 months