OssDsign® Spine Registry Study ("Propel")

NCT ID: NCT05329129

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-23

Study Completion Date

2027-04-01

Brief Summary

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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

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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.

Conditions

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Degenerative Disc Disease Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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OssDsign® Catalyst

An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OssDsign

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie Marshall

Role: STUDY_DIRECTOR

OssDsign

Locations

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Community Health Partners Neuroscience

Fresno, California, United States

Site Status RECRUITING

San Diego Neurosurgery

San Diego, California, United States

Site Status TERMINATED

Orthopedic Associates of Hartford

Hartford, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Central Connecticut Neurosurgery and Spine

New Britian, Connecticut, United States

Site Status RECRUITING

Yale Center for Clinical Investigation, Yale School of Medicine

New Haven, Connecticut, United States

Site Status RECRUITING

Minimally Invasive Spine Center of South Florida

Miami, Florida, United States

Site Status RECRUITING

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Site Status RECRUITING

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Carle Foundation Hospital, NeuroScience Institute

Urbana, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

OrthoBethesda Research Foundation

Bethesda, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Twin Cities Orthopedics

Edina, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

University Orthopedics Center

State College, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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jeff Feldhaus

Role: CONTACT

13476694903

Pete weiman

Role: CONTACT

13479540542

Facility Contacts

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Lizbeth Gasga-Rodriquez, CRC

Role: primary

Charles Curtiss

Role: primary

860-225-1227

Edgar Benitez, MD, MS

Role: primary

203-393-6591

Manuel Avedissian, MD, MS

Role: backup

Nicole Graveran

Role: primary

Debbi Warren

Role: primary

844-944-4263

Jill Fremberg, RN

Role: primary

814-272-3751

Other Identifiers

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OSD202101

Identifier Type: -

Identifier Source: org_study_id

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