lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1). M53.2
Conditions
Interventions
Group 1: Orthoss® as a bone graft extender in lumbar spondylodesis involving 1-2 levels (L4-L5 and/or L5-S1).
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance is evaluated by the success (yes/no) of the fusion by Functional X-ray Analysis (FXA) at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints concern clinical safety and performance. Safety will be measured with: • Assessment of AE • A SAE related to the medical device • Reoperation Performance will be measured with: • Decrease in Visual Analog Scale for Pain (VAS) for back and leg by 3/10 or more at 24 months from the pre-operative value. • Improvement in Oswestry Low Back Disability (ODI) of 15 or more at 24 months from the pre-operative value. • Evidence of bridging trabecular bone between the involved motion segments. | — |
Countries
Germany
Contacts
Public ContactFabiana Martinelli
Geistlich Pharma AG
Outcome results
None listed