Clinical trial NCT05329129: OssDsign® Spine Registry Study ("Propel")
Official title: PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Disc Disease
Spinal Stenosis
Keywords: Synthetic bone grafts
Degenerative Disc Disease
Bone fusion
Lead sponsor: OssDsign
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with as a candidate for spinal fusion surgery

Brief summary: The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.

Detailed description: This multi-center study (up to 15 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 450 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.

Eligibility criteria: * The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.
* The patient is ≥21 years old.
* The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
* The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.

Exclusion Criteria:

* Patients not meeting all of the inclusion criteria

Primary outcomes:
measure: Rate of bone fusion
timeFrame: 12 months ± 60 days post-operative examination
Secondary outcomes:
measure: Quality of Life Questionnaire: Oswestry Disability Index
timeFrame: Up to 4 months, 6, 12 and 24 months
measure: Quality of Life Questionnaire: Neck Disability Index (NDI)
timeFrame: Up to 4 months, 6, 12 and 24 months
measure: Quality of Life Questionnaire: Visual Analog Scale (VAS)
timeFrame: Up to 4 months, 6, 12 and 24 months
measure: Quality of Life Questionnaire: Short Form 36 (SF-36)
timeFrame: Up to 4 months, 6, 12 and 24 months
measure: Neurological Function
timeFrame: Up to 4 months, 6, 12 and 24 months
measure: Presence of bone fusion
timeFrame: 6, 12 and 24 months
measure: Safety review of device related AE's
timeFrame: Throughout study, 24 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Health Partners Neuroscience
state: California
city: San Diego
country: United States
facility: San Diego Neurosurgery
state: California
city: Hartford
country: United States
facility: Orthopedic Associates of Hartford
state: Connecticut
city: New Britian
country: United States
facility: Central Connecticut Neurosurgery and Spine
state: Connecticut
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation, Yale School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Minimally Invasive Spine Center of South Florida
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Urbana
country: United States
facility: Carle Foundation Hospital, NeuroScience Institute
state: Illinois
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Bethesda
country: United States
facility: OrthoBethesda Research Foundation
state: Maryland
city: Edina
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
Study officials:
affiliation: OssDsign
name: Melanie Marshall
role: STUDY_DIRECTOR
References: