OssDsign® Spine Registry Study ("Propel")

Last updated: April 8, 2025
Sponsor: OssDsign
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spondylolisthesis

Spinal Stenosis

Treatment

OssDsign® Catalyst

Clinical Study ID

NCT05329129
OSD202101
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • The patient has been diagnosed as a candidate for spinal fusion surgery for whichthe 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, andphysically able to fully comply with this protocol, including the post-operativeregimen, required follow-up visits, the filling out of required forms, and have theability to understand and give written informed consent

  • The patient is willing and able to participate in post- operative clinical andradiographic follow up evaluations for 2 years.

Exclusion

Exclusion Criteria:

  • Patients not meeting all of the inclusion criteria

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: OssDsign® Catalyst
Phase:
Study Start date:
March 23, 2022
Estimated Completion Date:
April 01, 2027

Study 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.

Connect with a study center

  • Community Health Partners Neuroscience

    Fresno, California 93720
    United States

    Active - Recruiting

  • San Diego Neurosurgery

    San Diego, California 92024
    United States

    Terminated

  • Orthopedic Associates of Hartford

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Central Connecticut Neurosurgery and Spine

    New Britian, Connecticut 06051
    United States

    Active - Recruiting

  • Yale Center for Clinical Investigation, Yale School of Medicine

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • Minimally Invasive Spine Center of South Florida

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Foundation for Orthopaedic Research and Education

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Northeast Georgia Medical Center

    Gainesville, Georgia 30501
    United States

    Active - Recruiting

  • Carle Foundation Hospital, NeuroScience Institute

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • OrthoBethesda Research Foundation

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Twin Cities Orthopedics

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • University Orthopedics Center

    State College, Pennsylvania 16801
    United States

    Active - Recruiting

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