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

September 9, 2020 updated by: Globus Medical Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Saint Albans, Vermont, United States, 05478
        • Northwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be screened according to inclusion/exclusion criteria and will be selected for the treatment using the SI-LOK® system

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SI-Joint Dysfunction
Device- SI-LOK
Device: SI-LOK
Sacro-iliac joint fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Evaluation
Time Frame: 2 years
Fusion Assessment Radiolucency
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization Data
Time Frame: Intra-Operative
Operative Time Blood Loss Blood Transfusion Hospitalization Time
Intra-Operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Patient Self-Assessments
Time Frame: 2 years
Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Globus Medical Inc

Investigators

  • Principal Investigator: Michael Barnum, MD, Northwestern Medical Center, St Albans, VT 05478

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2013

Primary Completion (ACTUAL)

July 5, 2018

Study Completion (ACTUAL)

April 11, 2019

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGC12-004_PL_C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Joint Dysfunction

Clinical Trials on SI-LOK

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe