Clinical trial NCT05628142: Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study
Official title: Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Joint Disruption
Degenerative Sacroiliitis
Lead sponsor: Tenon Medical
Sponsor class: INDUSTRY
First posted: 2022-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Radiographic Fusion
timeFrame: 6-12 month post CATAMARAN Fixation Device implantation
Secondary outcomes:
measure: Device Status
timeFrame: 6-12 months post-op
measure: Surgical re-intervention for SI joint pain
timeFrame: 6-12 months post-op
measure: Neurologic worsening related to the sacral spine
timeFrame: 6-12 months post-op
measure: Serious device related adverse events
timeFrame: 6-12 months post-op
Other outcomes:
Locations:
city: Plano
country: United States
facility: Minimally Invasive Neurosurgery of Texas
state: Texas
city: Saint George
country: United States
facility: St. George Orthopaedic Spine
state: Utah
Study officials:
References: