Sacroiliac Joint DysfunctionSAIFNCT02064322
SAIF: Sacroiliac Fusion Study
An observational study of Sacroiliac Joint Dysfunction, run by Zyga Technology, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- SImmetry Implant
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates' for SIJ fusion.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.
Read the 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.)
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- SImmetry Implant
- Keywords
- sacroiliac joint fusion, SIJ fusion, SI joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SImmetry ImplantDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SImmetry Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
SI Joint Pain Reduction
SI joint pain reduction evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to all follow-up visits.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zyga Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064322
- Sponsor's protocol ID
- CLP 007-001
- Acronym
- SAIF
- Status last verified
- Mar 2016
- First submitted
- 12 Feb 2014
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAIF: Sacroiliac Fusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
- ClinicalTrials.gov ID
- NCT02064322
- Acronym / sponsor ID
- SAIF / CLP 007-001
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- sacroiliac joint fusion, SIJ fusion, SI joint
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Zyga Technology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SImmetry Implant | – | Device: SImmetry ImplantSubjects who are indicated for the SImmetry Device according to the approved product labeling and inclusion/exclusion criteria will receive a SImmetry implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the Investigator's standard patient population diagnosed with SIJ pain and representing candidates' for SIJ fusion.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SImmetry ImplantThe 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. | Device | SImmetry Implant |
Primary outcome
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.
1 secondary outcome
SI Joint Pain Reduction
Time frame: 12 and 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction, run by Zyga Technology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SI Joint Fusion (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.