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

Joint Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861899
• Other study ID #: RGC12-004_PL_C
• Status: Completed
• Start date: May 2, 2013
• Est. completion date: April 11, 2019

Study information

• Verified date: September 2020
• Source: Globus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 11, 2019
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Joint Dysfunction

Intervention

Device:
• SI-LOK
Sacro-iliac joint fusion

Locations

Country	Name	City	State
United States	Northwestern Medical Center	Saint Albans	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Globus Medical Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite of Patient Self-Assessments	Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction	2 years
Primary	Radiographic Evaluation	Fusion Assessment Radiolucency	2 years
Secondary	Hospitalization Data	Operative Time Blood Loss Blood Transfusion Hospitalization Time	Intra-Operative