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SacroiliitisSPARTANNCT05916092

Post-Market Clinical Study on a Modular SI Joint Fusion System

An observational study of Sacroiliitis and Sacroiliac Joint Dysfunction, run by CornerLoc at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Sacroiliitis, Sacroiliac Joint Dysfunction
What is being tested?
TransLoc 3D
Type of treatment
Medical device
How many people
240 participants
Where
1 siteUnited States
Study dates
19 Oct 2023to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive enrollment of all patients within inclusion criteria.

Who may be able to join

  • Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
  • Age 18-85* (*Over 85 is allowed with H\&P assessment screening upon approval by Medical Monitor);
  • Absent condition of high-risk surgical candidate (see training manual for definition);
  • Patient has lower back pain with a confirmed diagnosis of sacroiliac joint disruption or degenerative sacroiliitis for a period of >6 months and who has not responded to optimal conservative care (PT or prescribed HEP, optimal medical management including NSAIDs);
  • Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. at least three positive findings with provocative maneuvers (FABER, Gaenslen, Thigh Thrust or Posterior Shear, SI Compression, SI Distraction, and Yeoman Test);
  • Patient has a diagnostic SIJ injection (SIJI) that provided a minimum of 75% relief of primary (index) pain with the diagnostic SIJI on two separate occasions;
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  • Patient meets Medicare and payer requirements for medical necessity, see detailed requirements in training manual;
  • SI joint disruption: Asymmetric SI joint widening on X-ray or CT scan or degenerative sacroiliitis with radiographic evidence of SIJ degeneration as evidenced on CT or X-ray;
  • SI joint pain or instability with or without prior lumbar/lumbosacral surgery;
  • Baseline Oswestry Disability Index (ODI) score of at least 30%;
  • Baseline SI joint pain score of at least 60 on 0-100mm visual analog scale (or at least a 6 on NRS);
  • Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements;
  • Failed SIJ fusion revisions can be included if all other inclusion criteria are met;
  • Patient must be able to communicate with study personnel via phone, text, or email;
  • PI must confirm women of childbearing years are not pregnant or plan to become pregnant prior to surgery;
  • Cardiac Clearance for patients with diagnosis of cardiac disease;
  • Patient has signed study-specific informed consent form.

Who cannot join

  • Patient will not be entered into the study if they meet one of the following criteria:
  • Current severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, lumbar radicular pain that extends beyond the mid-thigh, and lumbar vertebral body fracture;
  • SIJ pain secondary to inflammatory conditions or other known sacroiliac pathology such as: Sacral dysplasia, Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondylo-arthropathy), Tumor or infection in the SI joint, Acute fracture or Crystal arthropathy;
  • History of recent (<1 year) major trauma to pelvis (MVA or significant accident that results in acute injury to pelvis requiring hospitalization or surgery);
  • Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture). If patient meets the osteoporosis screening criteria identified by the National Osteoporosis Foundation, they should be screened for osteoporosis with DEXA;
  • Autoimmune - patient who is currently not maintained on a medication regimen for treatment, and not stable (<6 months without exacerbation);
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  • Any condition or anatomy that makes treatment with the TransLoc 3D Sacroiliac Joint Fusion System infeasible;
  • Current local or systemic infection that raises the risk of surgery;
  • Patient currently receiving disability remuneration, and/or involved in injury litigation;
  • Patient is undergoing treatment under Workman's Compensation under a claim or injury greater than 1 year;
  • Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation;
  • Known to be pregnant, suspected pregnant, or planning to be pregnant prior to SIJ surgery;
  • Patient is a prisoner or a ward of the state;
  • Known or suspected drug or alcohol abuse;
  • Known allergy to titanium or titanium alloys;
  • Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that is not well controlled for a minimum of two years and could interfere with study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NY Spine and Pain Specialists

    Port Jefferson Station, New York, 11776

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Post Market Surveillance Study on a Modular SI Joint Fusion System

A prospective study on the use of the TransLoc 3D SI Joint Fusion System for patients with sacroiliac joint disruptions or degenerative sacroiliitis.

Read the detailed description

Multicenter, prospective, post-market surveillance study on the TransLoc 3D Sacroiliac Joint Fusion System including two treatment arms: 1) Lateral-Oblique TransLoc 3D Screw(s), 2) Lateral Oblique TransLoc 3D Screw with Posterior Device (Hybrid). Data from this post-market study will be used to support knowledge of clinical efficacy and improvement with the use of TransLoc 3D Sacroiliac Joint Fusion System.

Being tested
TransLoc 3D
Medical subject headings
Sacroiliitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TransLoc 3DDevice

    TransLoc 3D SI Joint Fusion System

Study groups in NCT05916092
Study groupRoleWhat they receive
Lateral-Oblique TransLoc 3D Screw(s)Patients receiving the TransLoc 3D Screw(s) version will receive screw(s) placed lateral-obliquely into the intended SI joint.
Receives: Device: TransLoc 3D
Lateral Oblique TransLoc 3D Screw with Posterior Device (Hybrid)Patients receiving the TransLoc 3D Hybrid construct will receive one 3D-printed titanium screw placed lateral-obliquely and one 3D-printed titanium posterior device across the same sacroiliac joint.
Receives: Device: TransLoc 3D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement at 12 months defined by a composite score of functional status, pain, and safety events.

    Functional improvement and pain score have long been the standard for SI joint improvement measures. Multiple functional improvement scales will be assessed throughout the study.

    Measured: 12 months

  2. Absence of Serious Adverse Events (SAEs)

    Demonstrate safety as defined by Serious Adverse Events (SAEs).

    Measured: From the time informed consent is signed through 12 months.

Secondary outcomes (1)

  1. Absence of study-related adverse events

    Evaluate any study-related adverse events for the duration of the study.

    Measured: 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start19 Oct 2023
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916092
Sponsor's protocol ID
SPARTAN-001
Acronym
SPARTAN
Status last verified
Mar 2026
First submitted
13 Jun 2023
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sacroiliitis and Sacroiliac Joint Dysfunction, run by CornerLoc at 1 site 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 17 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Clinical improvement at 12 months defined by a composite score of functional status, pain, and safety events. (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?

On the ClinicalTrials.gov record for NCT05916092.

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 27 Oct 2026.

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