Sacroiliac Joint DysfunctionNCT02074761
Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
An observational study of Sacroiliac Joint Dysfunction, run by Surgalign Spine Technologies at 22 sites in United States.
Trial 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. 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
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 22 sitesUnited States
- Study dates
- 6 Jan 2015to Nov 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Tristate Brain and Spine Institute
Alexandria, Minnesota, 56308
Bellevue Bone and Joint Physicians
Bellevue, Washington, 98004
Fourth Corner Neurological Associates
Bellingham, Washington, 98225
Regional Brain and Spine
Cape Girardeau, Missouri, 63701
Medical University of South Carolina
Charleston, South Carolina, 29425
DK Orthopaedics
Crown Point, Indiana, 46307
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, 32117
Essentia Health
Duluth, Minnesota, 55805
SBA Medical Center
El Dorado, Kansas, 67042
Gainesville Physical Therapy
Gainesville, Georgia, 30506
Western Michigan University Homer Stryker MD School of Medicine
Kalamazoo, Michigan, 49008
Rocky Mountain Spine Clinic
Lone Tree, Colorado, 80124
BASIC Spine
Newport Beach, California, 92660
Kaiser Permanente
Oakland, California, 94611
Central Florida Neurosurgery Institute
Orlando, Florida, 32801
The CORE Institute
Phoenix, Arizona, 85023
Portland Pain and Spine
Portland, Oregon, 97229
Black Hills Orthopedic & Spine Center
Rapid City, South Dakota, 57702
Flagler Hospital
Saint Augustine, Florida, 32086
University of Utah
Salt Lake City, Utah, 84108
Northwest Orthopaedic Specialists
Spokane, Washington, 99208
Azalea Orthopedics
Tyler, Texas, 75701
About this study
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
Read the 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.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- SImmetry
- Keywords
- sacroiliac joint fusion, SIJ fusion, SI joint, SIJ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SImmetryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SImmetry Implant | Subjects who are indicated for the SImmetry device and meet the inclusion/exclusion criteria will receive a SImmetry implant. Receives: Device: SImmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
SI Joint Fusion
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
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 (3)
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 months
Disability
Functional ability as determined by the Oswestry Disability Index
Measured: 6 months
Quality of Life
Quality of life as determined by EQ-5D
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study start6 Jan 2015
- Primary completionAug 2019
- Study completionNov 2020 (estimated)
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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgalign Spine Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074761
- Sponsor's protocol ID
- CLP 007-002
- Status last verified
- Oct 2020
- First submitted
- 26 Feb 2014
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System
- ClinicalTrials.gov ID
- NCT02074761
- Acronym / sponsor ID
- CLP 007-002
- Conditions
- Sacroiliac Joint Dysfunction
- Keywords
- sacroiliac joint fusion, SIJ fusion, SI joint, SIJ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Surgalign Spine TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 28 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.
Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SImmetry Implant | – | Device: SImmetrySubjects who are indicated for the SImmetry device and meet the 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 (5 listed)
- 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 (5 listed)
- 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
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 |
|---|---|---|
| SImmetryThe 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. | Device | SImmetry Implant |
Primary outcome
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
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.
3 secondary outcomes
SI Joint Pain Reduction
Time frame: 12 months
Disability
Time frame: 6 months
Quality of Life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac Joint Dysfunction, run by Surgalign Spine Technologies at 22 sites in United States.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 12 Oct 2020.