Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | August 2017 |
| Contact: | Gita Joshua |
| Email: | gjoshua@globusmedical.com |
| Phone: | 610-930-1800 |
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.
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.
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.
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.
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
We found this trial at
1
site
St Albans, Vermont 05478
Principal Investigator: Michael Barnum, MD
Phone: 802-524-5911
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