OssDsign® Spine Registry Study ("Propel")
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorOssDsign
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients not meeting all of the inclusion criteria
Trial population
Patients diagnosed with as a candidate for spinal fusion surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
OssDsign® Catalyst
DeviceAn osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months ± 60 days post-operative examinationSecondary outcomes
1
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).
Time frame
Up to 4 months, 6, 12 and 24 months2
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).
Time frame
Up to 4 months, 6, 12 and 24 months3
Quality of Life Questionnaire: Visual Analog Scale (VAS)
A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)
Time frame
Up to 4 months, 6, 12 and 24 months4
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
Time frame
Up to 4 months, 6, 12 and 24 months Source ClinicalTrials.gov