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OpenTrials
Completed

NCT Number: NCT01861899

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Medical Center

Saint Albans, Vermont, 05478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SI-LOK

Device

Sacro-iliac joint fusion

Primary outcomes

  1. Radiographic Evaluation

    Time frame: 2 years

    Fusion Assessment Radiolucency

Secondary outcomes

  1. Hospitalization Data

    Time frame: Intra-Operative

    Operative Time Blood Loss Blood Transfusion Hospitalization Time

Other outcomes

  1. Composite of Patient Self-Assessments

    Time frame: 2 years

    Back and Leg Pain Measured by Visual Analog Scale Oswestry Disability Index (ODI) Patient Satisfaction

Sponsors and collaborators

Lead sponsor

Globus Medical Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
May 24, 2013
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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