OssDsign® Spine Registry Study ("Propel")

February 7, 2024 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

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

300

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 Locations

  • United States
    • California
      • Fresno, California, United States, 93720
        • Recruiting
        • Community Health Partners Neuroscience
        • Contact:
        • Principal Investigator:
          • Derek Taggard, MD
      • San Diego, California, United States, 92024
        • Terminated
        • San Diego Neurosurgery
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Orthopedic Associates of Hartford
        • Contact:
        • Principal Investigator:
          • Hereen Makanji
      • 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
        • Contact:
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Medical Center
        • Contact:
        • Principal Investigator:
          • Tristin Stani, MD
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Foundation Hospital, NeuroScience Institute
        • Contact:
        • Principal Investigator:
          • Suguna Pappu, MD
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Active, not recruiting
        • Orthopaedic Institute of Western Kentucky
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • OrthoBethesda Research Foundation
        • Contact:
        • Principal Investigator:
          • Joseph O'Brian, 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

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

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

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

OssDsign

Investigators

  • 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)

March 23, 2022

Primary Completion (Estimated)

March 23, 2024

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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