Clinical Trial Finder

Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05628142
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Tenon Medical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sacroiliac Joint Disruption, Degenerative Sacroiliitis
Additional Details

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.

Arms & Interventions

Arms

Other: CATAMARAN SI Joint Fusion System

Subjects previously treated with the CATAMARAN Fixation Device

Interventions

Radiation: - Pelvic CT Scan

Pelvic CT-Scan between 6-12 months post-op

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Minimally Invasive Neurosurgery of Texas, Plano, Texas

Status

Address

Minimally Invasive Neurosurgery of Texas

Plano, Texas, 75024

St. George Orthopaedic Spine, Saint George, Utah

Status

Address

St. George Orthopaedic Spine

Saint George, Utah, 84790

Powered By