NCT01861899

Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK

Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.

Detailed description

Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient. Forms completed by patients will be checked, initialed and dated by the site coordinator. Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P \< 0.05 significance level.

Conditions

• Joint Dysfunction

Interventions

Type	Name	Description
DEVICE	SI-LOK	Sacro-iliac joint fusion

Timeline

• Start date: 2013-05-02
• Primary completion: 2018-07-05
• Completion: 2019-04-11
• First posted: 2013-05-24
• Last updated: 2020-09-11

Locations

1 site across 1 country: United States