Degenerative Disc DiseaseNCT05329129
OssDsign® Spine Registry Study ("Propel")
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by OssDsign at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis
- What is being tested?
- OssDsign® Catalyst
- Type of treatment
- Medical device
- How many people
- 450 participants
- Where
- 16 sitesUnited States
- Study dates
- 23 Mar 2022to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with as a candidate for spinal fusion surgery
Who may be able to join
None listed.
Who cannot join
- Patients not meeting all of the inclusion criteria
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anne McKibbin contact
16 sites in 1 country
United States16 sites, 8 recruiting
- Recruiting
Texas Spine Consultants
Addison, Texas, 75001
Kimberly Myers, 214-370-3535, haariss@ilyas.com
Haariss S Ilyas, MD
- Completed
OrthoBethesda Research Foundation
Bethesda, Maryland, 20817
- Active, not recruiting
Twin Cities Orthopedics
Edina, Minnesota, 55435
- Recruiting
Community Health Partners Neuroscience
Fresno, California, 93720
Lizbeth Gasga-Rodriquez, CRC, Lgasgarodriguez@communitymedical.org
Derek Taggard, MD
- Active, not recruiting
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
- Recruiting
Orthopedic Associates of Hartford
Hartford, Connecticut, 06102
Bethany Samperi, Bethany.Samperi@hhchealth.org
Hereen Makanji
- Recruiting
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806
Clinical Research Asociate, 714-858-8535, nanettemsoto@gmail.com
Philip S Yuan, MD
- Recruiting
Minimally Invasive Spine Center of South Florida
Miami, Florida, 33133
Nicole Graveran, nicoleg@miamiorthospine.com
Jonathan Gottlieb, MD
- Recruiting
Central Connecticut Neurosurgery and Spine
New Britian, Connecticut, 06051
Charles Curtiss, 860-225-1227, ccurtiss@centralctneuro.com
Ahmed Khan, MD
- Active, not recruiting
Yale Center for Clinical Investigation, Yale School of Medicine
New Haven, Connecticut, 06519
- Completed
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
- Terminated
San Diego Neurosurgery
San Diego, California, 92024
- Recruiting
Michigan Orthopaedic Surgeons
Southfield, Michigan, 48033
Reily Nessen, 248-416-1243, reily@researchtex.com
Jad Khalil, MD
- Recruiting
University Orthopedics Center
State College, Pennsylvania, 16801
Jill Fremberg, RN, 814-272-3751, jfremberg@ouc.com
James Burke, M.D., PhD., FAANS
- Active, not recruiting
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
- Completed
Carle Foundation Hospital, NeuroScience Institute
Urbana, Illinois, 61801
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis
- Being tested
- OssDsign® Catalyst
- Keywords
- Synthetic bone grafts, Degenerative Disc Disease, Bone fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OssDsign® CatalystDevice
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months ± 60 days post-operative examination
Secondary outcomes (7)
Quality of Life Questionnaire: Oswestry Disability Index
A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled).
Measured: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Neck Disability Index (NDI)
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).
Measured: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Visual Analog Scale (VAS)
A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)
Measured: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Short Form 36 (SF-36)
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
Measured: Up to 4 months, 6, 12 and 24 months
Neurological Function
All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician
Measured: Up to 4 months, 6, 12 and 24 months
Presence of bone fusion
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.
Measured: 6, 12 and 24 months
Safety review of device related AE's
Review of Adverse Events
Measured: Throughout study, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start23 Mar 2022
- Primary completion23 Mar 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OssDsign
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melanie Marshall, Study director, OssDsign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329129
- Sponsor's protocol ID
- OSD202101
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
- ClinicalTrials.gov ID
- NCT05329129
- Acronym / sponsor ID
- OSD202101
- Conditions
- Degenerative Disc Disease, Spinal Stenosis
- Keywords
- Synthetic bone grafts, Degenerative Disc Disease, Bone fusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- OssDsignIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 23 Mar 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with as a candidate for spinal fusion surgery
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients not meeting all of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OssDsign® CatalystAn osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler | Device | – |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne McKibbin contact
Melanie Marshall study director
OssDsign
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by OssDsign at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jeff Feldhaus (13476694903, jfeldhaus@msquaredassociates.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of bone fusion (time frame: 12 months ± 60 days post-operative examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.