Actively Recruiting
Prospective Observational Spine Fusion Registry for OssDsign AE Bone Graft Substitutes in Real-World Clinical Practice
Led by OssDsign · Updated on 2026-06-08
450
Participants Needed
15
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect information on the real-world use and clinical outcomes of OssDsign AE bone graft substitutes in patients needing spine fusion surgery. It is a multi-center, prospective, observational registry involving up to 25 US study sites. The study focuses on post-market surveillance to monitor the performance of OssDsign AE products in routine clinical practice for conditions like degenerative disc disease and spinal stenosis. Participants will receive spine fusion surgery using OssDsign AE bone grafts, specifically the OssDsign AE Catalyst device, which is a porous, synthetic calcium phosphate bone void filler. The study plans to recruit about 750 participants initially, who will be followed for up to 24 months B1 90 days after their surgery. This period allows evaluation of the bone fusion process and related outcomes over time. During the study, participants will undergo clinical and radiographic follow-up assessments at various intervals, including 6, 12, and 24 months post-surgery. Researchers will measure the rate of bone fusion at 12 months and monitor quality of life through questionnaires assessing disability and pain, as well as neurological function. Safety will also be reviewed continuously for any device-related adverse events throughout the two-year follow-up period.
CONDITIONS
Brief Title
OssDsign® Spine Registry Study ("Propel")
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient is 21 years or older
- The patient has been diagnosed as a candidate for spinal fusion surgery where an OssDsign�AE bone graft is appropriate
- The patient is mentally, physically, and psychosocially able to comply with the study protocol, including follow-up visits and forms
- The patient is willing and able to participate in post-operative clinical and radiographic follow-up evaluations for 2 years
You will not qualify if you...
- Patients not meeting all of the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Index surgery day
Participants undergo spine fusion surgery with implantation of the OssDsign® bone graft.
1 visit (in-person)
Duration - 24 months ± 90 days after surgery
Participants are followed up with clinical and radiographic evaluations to assess bone fusion, neurological function, and quality of life.
Visits at up to 4 months, 6 months, 12 months, and 24 months post-surgery
Trial Site Locations
Total: 15 locations
1
Community Health Partners Neuroscience
Fresno, California, United States, 93720
Actively Recruiting
2
Memorial Orthopaedic Surgical Group
Long Beach, California, United States, 90806
Actively Recruiting
3
San Diego Neurosurgery
San Diego, California, United States, 92024
Terminated
4
Orthopedic Associates of Hartford
Hartford, Connecticut, United States, 06102
Active, Not Recruiting
5
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut, United States, 06051
Actively Recruiting
6
Yale Center for Clinical Investigation, Yale School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
7
Minimally Invasive Spine Center of South Florida
Miami, Florida, United States, 33133
Actively Recruiting
8
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33607
Actively Recruiting
9
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Active, Not Recruiting
10
Carle Foundation Hospital, NeuroScience Institute
Urbana, Illinois, United States, 61801
Completed
11
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42001
Completed
12
OrthoBethesda Research Foundation
Bethesda, Maryland, United States, 20817
Active, Not Recruiting
13
Twin Cities Orthopedics
Edina, Minnesota, United States, 55435
Active, Not Recruiting
14
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Actively Recruiting
15
Texas Spine Consultants
Addison, Texas, United States, 75001
Not Yet Recruiting
Research Team
J
jeff Feldhaus
P
Pete weiman
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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