Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
NCT ID: NCT01861899
Last Updated: 2020-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2013-05-02
2019-04-11
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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SI-Joint Dysfunction
Device- SI-LOK
SI-LOK
Sacro-iliac joint fusion
Interventions
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SI-LOK
Sacro-iliac joint fusion
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SIJ dysfunction
* Ability to provide Informed Consent for study participation and to return for all follow-up visits
Exclusion Criteria
* 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
21 Years
70 Years
ALL
No
Sponsors
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Globus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Barnum, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Medical Center, St Albans, VT 05478
Locations
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Northwestern Medical Center
Saint Albans, Vermont, United States
Countries
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Other Identifiers
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RGC12-004_PL_C
Identifier Type: -
Identifier Source: org_study_id
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