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Trial record 1 of 37 for:    SAIF
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SAIF: Sacroiliac Fusion Study (SAIF)

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ClinicalTrials.gov Identifier: NCT02064322
Recruitment Status : Terminated
First Posted : February 17, 2014
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Zyga Technology, Inc.

Brief Summary:
The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

Condition or disease Intervention/treatment
Sacroiliac Joint Dysfunction Device: SImmetry Implant

Detailed Description:
This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
Study Start Date : February 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Group/Cohort Intervention/treatment
SImmetry Implant
Subjects who are indicated for the SImmetry Device according to the approved product labeling and inclusion/exclusion criteria will receive a SImmetry implant.
Device: SImmetry Implant

The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, providing stability for intra-articular fusion.

The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion.





Primary Outcome Measures :
  1. SI Joint Fusion [ Time Frame: 12 months ]
    Confirmed fusion of the SI joint at 12 and 24 months, defined as as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium.

  2. SI Joint Pain Reduction [ Time Frame: 6 months ]
    SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.


Secondary Outcome Measures :
  1. SI Joint Pain Reduction [ Time Frame: 12 and 24 months ]
    SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates' for SIJ fusion.
Criteria

Inclusion Criteria:

  • Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
  • Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
  • Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
  • The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
  • The subject has VAS back pain score of ≥ 60 mm
  • The subject has an ODI ≥ 40%
  • The subject is at least 18 years of age and skeletally mature
  • The subject agrees and is able to comply with study requirements

Exclusion Criteria:

  • Subjects contraindicated per the cleared labeling will be excluded from participation in the study
  • The subject has pelvic soft tissue or bony tumors
  • The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
  • The subject has a history of a central nervous system (CNS) disorder(s)
  • The subject is pregnant or is planning on becoming pregnant in the next two years
  • The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
  • The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview
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Responsible Party: Zyga Technology, Inc.
ClinicalTrials.gov Identifier: NCT02064322    
Other Study ID Numbers: CLP 007-001
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by Zyga Technology, Inc.:
sacroiliac joint fusion
SIJ fusion
SI joint
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases