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Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

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ClinicalTrials.gov Identifier: NCT02074761
Recruitment Status : Active, not recruiting
First Posted : February 28, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Brief Summary:
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

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

Detailed Description:
This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
Actual Study Start Date : January 6, 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Group/Cohort Intervention/treatment
SImmetry Implant
Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant.
Device: SImmetry

The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, 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 ]
    Fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium. This will be assessed by an independent core laboratory

  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 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.

  2. Disability [ Time Frame: 6 months ]
    Functional ability as determined by the Oswestry Disability Index

  3. Quality of Life [ Time Frame: 6 months ]
    Quality of life assessment



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

Key Inclusion Criteria:

  • At least three positive provocative tests for SIJ pain
  • Non-operative management of SIJ pain for ≥ 6 months prior to surgery
  • At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain
  • VAS back pain score of ≥ 60 mm
  • The subject is at least 18 years of age

Key Exclusion Criteria:

  • Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit, or pelvic soft tissue or bony tumors
  • Pregnant or is planning on becoming pregnant in the next two years
  • Chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview.
  • Receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
  • History of significant emotional or psychosocial disturbance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074761


  Show 22 Study Locations
Sponsors and Collaborators
RTI Surgical

Responsible Party: RTI Surgical
ClinicalTrials.gov Identifier: NCT02074761     History of Changes
Other Study ID Numbers: CLP 007-002
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: August 2018

Keywords provided by RTI Surgical:
sacroiliac joint fusion
SIJ fusion
SI joint
SIJ

Additional relevant MeSH terms:
Joint Diseases
Ankylosis
Musculoskeletal Diseases