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

Globus Medical Inc46 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Joint Dysfunction

Interventions

SI-LOKDEVICE

Sacro-iliac joint fusion

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Medical Center

Saint Albans, Vermont, United States

Outcomes

Primary Outcomes

Radiographic Evaluation

Fusion Assessment Radiolucency

Time frame: 2 years

Secondary Outcomes

Hospitalization Data

Operative Time Blood Loss Blood Transfusion Hospitalization Time

Time frame: Intra-Operative

Data from ClinicalTrials.gov

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