OssDsign® Spine Registry Study ("Propel")

OssDsign450 enrolled

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.

This multi-center study (up to 15 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 450 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

450

Conditions

Degenerative Disc Disease Spinal Stenosis

Interventions

OssDsign® CatalystDEVICE

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

* 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

Locations (13)

Community Health Partners Neuroscience

Fresno, California, United States

RECRUITING

San Diego Neurosurgery

San Diego, California, United States

Outcomes

Primary Outcomes

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 examination

Secondary Outcomes

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).