Recruiting

OssDsign®

Sponsor:

OssDsign

Code:

NCT05329129

Conditions

Degenerative Disc Disease

Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

OssDsign® Catalyst

Study Details

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.

Conditions

Degenerative Disc Disease

Spinal Stenosis

Study ID

NCT05329129

Start date

Mar 23, 2022

Status verified date

Jun, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Mar 23, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Interventions

OssDsign® Catalyst

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

Primary outcome measure

  • Rate of bone fusion [ Time Frame: 12 months ± 60 days post-operative examination ]

Central Contacts and Locations

Central contacts

jeff Feldhaus

13476694903jfeldhaus@msquaredassociates.com

Pete weiman

13479540542pete.weiman@propharmagroup.com

Locations

Community Health Partners Neuroscience

Recruiting

Fresno, California, United States, 93720

Contacts

Lizbeth Gasga-Rodriquez, CRC

Lgasgarodriguez@communitymedical.org

Principal Investigator:

Derek Taggard, MD

Memorial Orthopaedic Surgical Group

Recruiting

Long Beach, California, United States, 90806

Contacts

Clinical Research Asociate

714-858-8535nanettemsoto@gmail.com

Principal Investigator:

Philip S Yuan, MD

Central Connecticut Neurosurgery and Spine

Recruiting

New Britian, Connecticut, United States, 06051

Contacts

Charles Curtiss

860-225-1227ccurtiss@centralctneuro.com

Principal Investigator:

Ahmed Khan, MD

Yale Center for Clinical Investigation, Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Edgar Benitez, MD, MS

203-393-6591Edgar.Benitez@yale.edu

Manuel Avedissian, MD, MS

manuel.avedissian@yale.edu

Principal Investigator:

Peter Whang, MD

Minimally Invasive Spine Center of South Florida

Recruiting

Miami, Florida, United States, 33133

Contacts

Nicole Graveran

nicoleg@miamiorthospine.com

Principal Investigator:

Jonathan Gottlieb, MD

Foundation for Orthopaedic Research and Education

Recruiting

Tampa, Florida, United States, 33607

Contacts

Debbi Warren

844-944-4263dwarren@foreonline.org

Principal Investigator:

Brooks Osburn, MD

University Orthopedics Center

Recruiting

State College, Pennsylvania, United States, 16801

Contacts

Jill Fremberg, RN

814-272-3751jfremberg@ouc.com

Principal Investigator:

James Burke, M.D., PhD., FAANS

More Information

Sponsor

OssDsign

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Synthetic bone grafts
  • Degenerative Disc Disease
  • Bone fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by OssDsign on 2026-06-08.