SAIF: Sacroiliac Fusion Study

NCT02064322 | Terminated

• 1 other identifier: CLP 007-001
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sacroiliac Joint Dysfunction

Keywords

sacroiliac joint fusion; SIJ fusion; SI joint

Outcome Measures

Primary Outcomes (2)

• SI Joint Fusion

  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.

  12 months

• SI Joint Pain Reduction

  SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 6 months.

  6 months

Secondary Outcomes (1)

• SI Joint Pain Reduction

  12 and 24 months

Study Arms (1)

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

Interventions

SImmetry Implant DEVICE

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.

SImmetry Implant

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zyga Technology, Inc.: lead

Study Design

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

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03