Clinical Trials in Germany / NCT03853356
Active, not recruiting
Observational
Evidence For Fusion In Spine With Orthoss®
NCT03853356 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Lumbar Spondylolisthesis Involving L4-L5Lumbar Spondylolisthesis Involving L5-S1Lumbar Spinal StenosisLumbar Disc Degeneration
Investigational drug(s) / intervention(s)
Orthoss
Orthoss: Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
Study summary
This study aims to evaluate the performance and safety of the Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
Eligibility
Inclusion Criteria:
* The patient (male or female) must be 18 years or older
* The patient must be a candidate diagnosed with either degenerative disc disease including 1-2 level (L4-L5 and/or L5-S1) or dysplasic spondylolisthesis (degree 1 or 2) or lumbar stenosis
* If the patient is of child-bearing potential, the patient confirms not to be pregnant
* The patient is able to comply with the clinical investigation-related procedures such as attending all follow-up procedures
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication
* The patient will not participate in another clinical investigation during this clinical investigation
Exclusion Criteria:
* General contraindications for surgical treatment are present
* The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
* The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon
* The patient is pregnant or nursing
* Women of childbearing age who are not using a highly effective method of birth control
* The patient has acute or chronic infection at the surgical site
* The patient has a known allergy to bovine bone material
* The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination
* Vulnerable population
* Patient is currently participating, or has participated in another clinical investigation within 6 months
Primary outcome measure(s)
- Fusion rate — 6 months
Successful fusion should be based on the translational motion \< 3mm as well as on the angular motion \< 5° at 6 months.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik | Augsburg | Germany | |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany | |
| Klinikum Magdeburg gGmbH | Magdeburg | Germany |
Other trials for the same condition
Surgical Treatment of Adjacent Segment Stenosis
Starting soon
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03853356 on ClinicalTrials.gov ↗ ← All trials in Germany