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Active Not Recruiting
NCT03853356
Evidence For Fusion In Spine With Orthoss®
Conditions: Lumbar Spondylolisthesis Involving L4-L5, Lumbar Spondylolisthesis Involving L5-S1, Lumbar Spinal Stenosis, Lumbar Disc Degeneration
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 65
Sponsor: Geistlich Pharma AG
Location: Universitätsklinikum Augsburg - Neurochirurgische Klinik und Poliklinik Augsburg
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 Criteria
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
Source: ClinicalTrials.gov (NCT03853356). StuddyBuddy aggregates publicly available trial information.