Sacroiliac Joint DisruptionNCT05628142
Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study
A study testing Pelvic CT Scan in people with Sacroiliac Joint Disruption and Degenerative Sacroiliitis, run by Tenon Medical at 2 sites in United States.
Trial summary
The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Disruption, Degenerative Sacroiliitis
- What is being tested?
- Pelvic CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System
- Patient implanted with the CATAMARAN Fixation Device within the last 12 months
- Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study
- Patient is willing and able to complete study follow-up requirements
Who cannot join
- Known or suspected active drug or alcohol abuse
- Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
- Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture)
- Prior diagnosis of tumor in sacrum or ilium
- Unstable fracture of sacrum and or ilium involving the targeted SIJ
- Osteomalacia or other metabolic bone disease
Show all 10Show fewer
- Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- Patient is pregnant or wishes to become pregnant during the study period
- Patient is not likely to comply with the follow-up evaluation schedule
- Patient is a prisoner or a ward of the state
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Minimally Invasive Neurosurgery of Texas
Plano, Texas, 75024
St. George Orthopaedic Spine
St. George, Utah, 84790
About this study
Official title: Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.
The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
Read the detailed description
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.
- Being tested
- Pelvic CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic CT ScanRadiation
Pelvic CT-Scan between 6-12 months post-op
| Study group | Role | What they receive |
|---|---|---|
| CATAMARAN SI Joint Fusion System | Other | Subjects previously treated with the CATAMARAN Fixation Device Receives: Radiation: Pelvic CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
Measured: 6-12 month post CATAMARAN Fixation Device implantation
Secondary outcomes (4)
Device Status
Radiographic assessment for device status: device placement, loosening, migration and/or breakage
Measured: 6-12 months post-op
Surgical re-intervention for SI joint pain
Proportion of patients requiring surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain
Measured: 6-12 months post-op
Neurologic worsening related to the sacral spine
Proportion of patients experiencing neurologic worsening related to the sacral spine compared to baseline
Measured: 6-12 months post-op
Serious device related adverse events
Summary of all serious device related adverse events
Measured: 6-12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Nov 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DisruptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tenon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628142
- Sponsor's protocol ID
- PTL016
- Status last verified
- Apr 2023
- First submitted
- 16 Nov 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.
- ClinicalTrials.gov ID
- NCT05628142
- Acronym / sponsor ID
- PTL016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tenon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Nov 2022 (actual)
- 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 objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
Detailed description
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CATAMARAN SI Joint Fusion System | Other | Radiation: Pelvic CT ScanSubjects previously treated with the CATAMARAN Fixation Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System
- Patient implanted with the CATAMARAN Fixation Device within the last 12 months
- Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study
- Patient is willing and able to complete study follow-up requirements
Key exclusion criteria (10 listed)
- Known or suspected active drug or alcohol abuse
- Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
- Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture)
- Prior diagnosis of tumor in sacrum or ilium
- Unstable fracture of sacrum and or ilium involving the targeted SIJ
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 |
|---|---|---|
| Pelvic CT ScanPelvic CT-Scan between 6-12 months post-op | Radiation | CATAMARAN SI Joint Fusion System |
Primary outcome
Radiographic Fusion
Time frame: 6-12 month post CATAMARAN Fixation Device implantation
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
4 secondary outcomes
Device Status
Time frame: 6-12 months post-op
Surgical re-intervention for SI joint pain
Time frame: 6-12 months post-op
Neurologic worsening related to the sacral spine
Time frame: 6-12 months post-op
Serious device related adverse events
Time frame: 6-12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic CT Scan in people with Sacroiliac Joint Disruption and Degenerative Sacroiliitis, run by Tenon Medical at 2 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 10 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Radiographic Fusion (time frame: 6-12 month post CATAMARAN Fixation Device implantation). 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 21 Apr 2023.