Ireland
--:--IST
Active, not recruiting Observational

Evidence For Fusion In Spine With Orthoss®

NCT03853356 · tracked via the Priya Life Science Germany tracker
Sponsor
Geistlich Pharma AG
Phase
Observational
Started
2019-01-18
Last updated
2026-09-11

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik Augsburg Germany
Universitätsklinikum Düsseldorf Düsseldorf Germany
Klinikum Magdeburg gGmbH Magdeburg Germany

Other trials for the same condition

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