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Recruiting

NCT Number: NCT05329129

OssDsign® Spine Registry Study ("Propel")

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.

Recruiting

Interested in participating?

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Health Partners Neuroscience, Fresno, California, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

OssDsign® Catalyst

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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)

  4. 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

  5. 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

  6. 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.

  7. Safety review of device related AE's

    Time frame: Throughout study, 24 months

    Review of Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

Pete weiman

CONTACT

[email protected]

13479540542

jeff Feldhaus

CONTACT

[email protected]

13476694903

Sponsors and collaborators

Lead sponsor

OssDsign

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 14, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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