NCT05329129

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2022Apr 2027

First Submitted

Initial submission to the registry

March 22, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 23, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2027

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 1, 2026

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

March 22, 2022

Last Update Submit

April 27, 2026

Conditions

Degenerative Disc DiseaseSpinal Stenosis

Keywords

Synthetic bone graftsDegenerative Disc DiseaseBone fusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Quality of Life Questionnaire: Oswestry Disability Index

    Up to 4 months, 6, 12 and 24 months

  • Quality of Life Questionnaire: Neck Disability Index (NDI)

    Up to 4 months, 6, 12 and 24 months

  • Quality of Life Questionnaire: Visual Analog Scale (VAS)

    Up to 4 months, 6, 12 and 24 months

  • Quality of Life Questionnaire: Short Form 36 (SF-36)

    Up to 4 months, 6, 12 and 24 months

  • Neurological Function

    Up to 4 months, 6, 12 and 24 months

  • +2 more secondary outcomes

Interventions

OssDsign® CatalystDEVICE

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

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with as a candidate for spinal fusion surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Community Health Partners Neuroscience

Fresno, California, 93720, United States

RECRUITING

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

RECRUITING

San Diego Neurosurgery

San Diego, California, 92024, United States

TERMINATED

Orthopedic Associates of Hartford

Hartford, Connecticut, 06102, United States

ACTIVE NOT RECRUITING

Central Connecticut Neurosurgery and Spine

New Britian, Connecticut, 06051, United States

RECRUITING

Yale Center for Clinical Investigation, Yale School of Medicine

New Haven, Connecticut, 06519, United States

RECRUITING

Minimally Invasive Spine Center of South Florida

Miami, Florida, 33133, United States

RECRUITING

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33607, United States

RECRUITING

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

ACTIVE NOT RECRUITING

Carle Foundation Hospital, NeuroScience Institute

Urbana, Illinois, 61801, United States

COMPLETED

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

COMPLETED

OrthoBethesda Research Foundation

Bethesda, Maryland, 20817, United States

ACTIVE NOT RECRUITING

Twin Cities Orthopedics

Edina, Minnesota, 55435, United States

ACTIVE NOT RECRUITING

University Orthopedics Center

State College, Pennsylvania, 16801, United States

RECRUITING

Texas Spine Consultants

Addison, Texas, 75001, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Melanie Marshall

    OssDsign

    STUDY DIRECTOR

Central Study Contacts

jeff Feldhaus

CONTACT

13476694903jfeldhaus@msquaredassociates.com

Pete weiman

CONTACT

13479540542pete.weiman@propharmagroup.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 14, 2022

Study Start

March 23, 2022

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 1, 2026

Record last verified: 2025-11

Locations

US(15)