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Recruiting NCT05329129

OssDsign® Spine Registry Study ("Propel")

— Observational Degenerative Disc Disease Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OssDsign® Catalyst.
Who it may be relevant to
Registry conditions: Degenerative Disc Disease, Spinal Stenosis. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Device OssDsign® Catalyst
    An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler

Primary outcome measures

  • Rate of bone fusion [Time frame: 12 months ± 60 days post-operative examination]
Secondary outcome measures (7)
  • Quality of Life Questionnaire: Oswestry Disability Index [Time frame: 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]
  • Quality of Life Questionnaire: Visual Analog Scale (VAS) [Time frame: 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]
  • Neurological Function [Time frame: Up to 4 months, 6, 12 and 24 months]
  • Presence of bone fusion [Time frame: 6, 12 and 24 months]
  • Safety review of device related AE's [Time frame: Throughout study, 24 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 15 centers
  • Community Health Partners Neuroscience — Fresno
  • Memorial Orthopaedic Surgical Group — Long Beach
  • San Diego Neurosurgery — San Diego
  • Orthopedic Associates of Hartford — Hartford
  • Central Connecticut Neurosurgery and Spine — New Britian
  • Yale Center for Clinical Investigation, Yale School of Medicine — New Haven
  • Minimally Invasive Spine Center of South Florida — Miami
  • Foundation for Orthopaedic Research and Education — Tampa
  • … and 7 more centers

Identifiers

NCT: NCT05329129 · OSD202101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗