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Trial record 1 of 36 for:    SAIF
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SAIF: Sacroiliac Fusion Study (SAIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date February 12, 2014
First Posted Date February 17, 2014
Last Update Posted Date March 31, 2016
Study Start Date February 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2015)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: February 14, 2014)
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.
Change History
Current Secondary Outcome Measures
 (submitted: April 6, 2015)
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.
Original Secondary Outcome Measures
 (submitted: February 14, 2014)
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 12 and 24 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SAIF: Sacroiliac Fusion Study
Official Title SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
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.
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.)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Sacroiliac Joint Dysfunction
Intervention 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.

Study Groups/Cohorts 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.
Intervention: Device: SImmetry Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: March 29, 2016)
2
Original Estimated Enrollment
 (submitted: February 14, 2014)
15
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT02064322
Other Study ID Numbers CLP 007-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Zyga Technology, Inc.
Study Sponsor Zyga Technology, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Zyga Technology, Inc.
Verification Date March 2016