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

Completed

Conditions studied: Joint Dysfunction

In brief

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.

Key facts

Study ID

NCT01861899

Run by

Globus Medical Inc

People needed

46

Starts

2013-05-02

Expected to finish

2019-04-11

Last updated by the study team

2020-09-11

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A maximum age of 70 years
• Diagnosis of SIJ dysfunction
• Ability to provide Informed Consent for study participation and to return for all follow-up visits

You may not qualify if…

• Previous documentation of osteopenia or osteomalacia
• History of metabolic bone disease (e.g. diabetes requiring daily insulin)
• Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
• Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
• History of substance abuse (drugs or alcohol)
• Condition that would preclude completing patient self assessment questionnaires
• Mentally incompetent or prisoner
• Currently a participant in another study

Where it is running

• Northwestern Medical Center — Saint Albans, Vermont, United States

Full record on ClinicalTrials.gov

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