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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:21 - 70
Updated:4/21/2016
Start Date:May 2013
End Date:August 2017
Contact:Gita Joshua
Email:gjoshua@globusmedical.com
Phone:610-930-1800

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

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
St Albans, Vermont 05478
Principal Investigator: Michael Barnum, MD
Phone: 802-524-5911
?
mi
from
St Albans, VT
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