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

Globus Medical

Status: Completed

Conditions: Joint Dysfunction

Treatments: Device: SI-LOK

Study type: Observational

Funder types: Industry

Identifiers

NCT01861899

RGC12-004_PL_C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 1 patient group

SI-Joint Dysfunction

Description:

Device- SI-LOK

Treatment:

Device: SI-LOK