Clinical trial NCT05640908: Pelvic Fixation and Fusion During Multilevel Spinal Surgery
Official title: Pelvic Fixation and Fusion During Multilevel Spinal Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spinal Fusion
Deformity of Spine
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal fusion including pelvic fixation/fusion using GRANITE

Brief summary: PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.

Detailed description: PAULA is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. The goal of the study is to collect data on the safety, performance, and effectiveness of GRANITE.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age at screening.
2. Patient is scheduled for spinal fusion with pelvic fixation/fusion using iFuse Bedrock Granite
3. Patient is willing and able to provide written informed consent

Exclusion Criteria:

1. Any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s)
2. Prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation
3. Known allergy to titanium or titanium alloys
4. Current local or systemic infection that raises the risk of surgery
5. Currently pregnant or planning pregnancy in the next 2 years
6. Known or suspected active drug or alcohol abuse, including opioids
7. Patient is a prisoner or ward of the state
8. Patient is enrolled in an investigational clinical trial related to the spine

Primary outcomes:
measure: Postoperative incidence of serious adverse events probably or definitely related to GRANITE
timeFrame: 2 years
measure: Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
timeFrame: 2 years
measure: Postoperative incidence of L5-S1 pseudoarthrosis
timeFrame: 2 years
measure: Postoperative incidence of pelvic construct failure
timeFrame: 2 years
measure: Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)
timeFrame: 2 years
measure: Radiographic
timeFrame: 12 month and 24 months
measure: Change in Quality of Life PROs
timeFrame: 6 month, 12 month and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Neurosurgery
state: Alabama
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Royal Oak
country: United States
facility: Corewell Health
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Pinehurst
country: United States
facility: Pinehurst Surgical Clinic
state: North Carolina
city: Houston
country: United States
facility: University of Texas Health, Houston
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: SI-BONE, Inc.
name: Robyn Capobianco, PhD
role: STUDY_DIRECTOR
References: