Status:
COMPLETED
Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
Lead Sponsor:
Globus Medical Inc
Conditions:
Joint Dysfunction
Eligibility:
All Genders
21-70 years
Brief 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 out...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01861899
Start Date
May 2 2013
End Date
April 11 2019
Last Update
September 11 2020
Active Locations (1)
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1
Northwestern Medical Center
Saint Albans, Vermont, United States, 05478