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

NCT01861899 | Completed

• 1 other identifier: RGC12-004_PL_C
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Dysfunction

Keywords

Sacro-iliac Joint

Outcome Measures

Primary Outcomes (1)

• Radiographic Evaluation

  Fusion Assessment Radiolucency

  2 years

Secondary Outcomes (1)

• Hospitalization Data

  Intra-Operative

Other Outcomes (1)

• Composite of Patient Self-Assessments

  2 years

Study Arms (1)

SI-Joint Dysfunction

Device- SI-LOK

Device: SI-LOK

Interventions

SI-LOK DEVICE

Sacro-iliac joint fusion

SI-Joint Dysfunction

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Globus Medical Inc: lead

Study Sites (1)

Northwestern Medical Center

Saint Albans, Vermont, 05478, United States

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Michael Barnum, MD

  Northwestern Medical Center, St Albans, VT 05478

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 24, 2013
• Study Start: May 2, 2013
• Primary Completion: July 5, 2018
• Study Completion: April 11, 2019
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)