Short Term Evaluation of SLIC Screw in Treatment of Scapholunate Injury

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury

Conditions
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Acute Scapholunate Injury

Intervention / Treatment
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* Device: Acumed Scapholunate Intercarpal Screw


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acumed Scapholunate Intercarpal Screw|Evaluation of provisional fixation to allow biologic healing of the scapholunate interval|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of reported VAS pain from preoperative to post-planned explantation | Planned removal of provisional device recommended between six and 9 months; 12-month analysis will capture time to planned removal. | 12 months | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation of device integrity | Device integrity defined as no device breakage or separation | 12 months | 
| 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 | Flexion, Extension, Radial Deviation, Ulnar Deviation | 12 months | 
| 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 |