OssDsign® Spine Registry Study ("Propel")

Degenerative Disc Disease Clinical Trial

Official title:

PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329129
• Other study ID #: OSD202101
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: OssDsign
• Contact: Jeff Feldhaus
• Phone: 13476694903
• Email: jfeldhaus[@]msquaredassociates.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This multi-center study (up to 10 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 300 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2027
• Est. primary completion date: March 23, 2027
• Gender: All
• Age group: 21 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Stenosis

Intervention

Device:
• OssDsign® Catalyst
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Locations

Country	Name	City	State
United States	OrthoBethesda Research Foundation	Bethesda	Maryland
United States	Twin Cities Orthopedics	Edina	Minnesota
United States	Community Health Partners Neuroscience	Fresno	California
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Orthopedic Associates of Hartford	Hartford	Connecticut
United States	Minimally Invasive Spine Center of South Florida	Miami	Florida
United States	Yale Center for Clinical Investigation, Yale School of Medicine	New Haven	Connecticut
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	San Diego Neurosurgery	San Diego	California
United States	University Orthopedics Center	State College	Pennsylvania
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida
United States	Carle Foundation Hospital, NeuroScience Institute	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OssDsign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bone fusion	Assessment of the rate of bone fusion via Computerized Tomography (CT)/x-ray based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level.	12 months ± 60 days post-operative examination
Secondary	Quality of Life Questionnaire: Oswestry Disability Index	A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled).	Up to 4 months, 6, 12 and 24 months
Secondary	Quality of Life Questionnaire: Neck Disability Index (NDI)	A self-reported questionnaire to determine how pain affects everyday life and assess the level of disability and scored from 0 (no disability) to 50 (complete disability).	Up to 4 months, 6, 12 and 24 months
Secondary	Quality of Life Questionnaire: Visual Analog Scale (VAS)	A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)	Up to 4 months, 6, 12 and 24 months
Secondary	Quality of Life Questionnaire: Short Form 36 (SF-36)	A Questionnaire used to measure the impact of clinical and social interventions using eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	Up to 4 months, 6, 12 and 24 months
Secondary	Neurological Function	All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician	Up to 4 months, 6, 12 and 24 months
Secondary	Presence of bone fusion	All subjects will undergo x-ray evaluation to include AP and neutral lateral views pre-operatively. At post-operative visits AP and neutral lateral x-rays, plus flexion and extension x-rays (if standard care) taken with the subject standing up and/or a CT scan taken.	6, 12 and 24 months
Secondary	Safety review of device related AE's	Review of Adverse Events	Throughout study, 24 months