OssDsign® Spine Registry Study ("Propel")

June 4, 2026 updated by: OssDsign

PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This multi-center study (up to 25 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 750 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93720
      • Long Beach, California, United States, 90806
        • Recruiting
        • Memorial Orthopaedic Surgical Group
        • Principal Investigator:
          • Philip S Yuan, MD
        • Contact:
      • San Diego, California, United States, 92024
        • Terminated
        • San Diego Neurosurgery
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Orthopedic Associates of Hartford
      • New Britian, Connecticut, United States, 06051
        • Recruiting
        • Central Connecticut Neurosurgery and Spine
        • Contact:
        • Principal Investigator:
          • Ahmed Khan, MD
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale Center for Clinical Investigation, Yale School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Whang, MD
    • Florida
      • Miami, Florida, United States, 33133
        • Recruiting
        • Minimally Invasive Spine Center of South Florida
        • Contact:
        • Principal Investigator:
          • Jonathan Gottlieb, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Foundation for Orthopaedic Research and Education
        • Contact:
        • Principal Investigator:
          • Brooks Osburn, MD
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Active, not recruiting
        • Northeast Georgia Medical Center
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Completed
        • Carle Foundation Hospital, NeuroScience Institute
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Completed
        • Orthopaedic Institute of Western Kentucky
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Active, not recruiting
        • OrthoBethesda Research Foundation
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Active, not recruiting
        • Twin Cities Orthopedics
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Recruiting
        • University Orthopedics Center
        • Contact:
        • Principal Investigator:
          • James Burke, M.D., PhD., FAANS
    • Texas
      • Addison, Texas, United States, 75001
        • Not yet recruiting
        • Texas Spine Consultants
        • Contact:
        • Principal Investigator:
          • Haariss S Ilyas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with as a candidate for spinal fusion surgery

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of bone fusion
Time Frame: 12 months ± 60 days post-operative examination
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life Questionnaire: Oswestry Disability Index
Time Frame: Up to 4 months, 6, 12 and 24 months
A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled).
Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Neck Disability Index (NDI)
Time Frame: Up to 4 months, 6, 12 and 24 months
A self-reported questionnaire to determine how pain affects everyday life and assess the level of disability and scored from 0 (no disability) to 50 (complete disability).
Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Visual Analog Scale (VAS)
Time Frame: Up to 4 months, 6, 12 and 24 months
A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)
Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Short Form 36 (SF-36)
Time Frame: Up to 4 months, 6, 12 and 24 months
A Questionnaire used to measure the impact of clinical and social interventions using eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Up to 4 months, 6, 12 and 24 months
Neurological Function
Time Frame: Up to 4 months, 6, 12 and 24 months
All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician
Up to 4 months, 6, 12 and 24 months
Presence of bone fusion
Time Frame: 6, 12 and 24 months
All subjects will undergo x-ray evaluation to include AP and neutral lateral views pre-operatively. At post-operative visits AP and neutral lateral x-rays, plus flexion and extension x-rays (if standard care) taken with the subject standing up and/or a CT scan taken.
6, 12 and 24 months
Safety review of device related AE's
Time Frame: Throughout study, 24 months
Review of Adverse Events
Throughout study, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OssDsign

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Melanie Marshall, OssDsign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSD202101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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