Evidence For Fusion In Spine with Orthoss®.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 65

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance is evaluated by the success (yes/no) of the fusion by Functional X-ray Analysis (FXA) at 6 months.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints concern clinical safety and performance. <br>Safety will be measured with:<br>• Assessment of AE<br>• A SAE related to the medical device<br>• Reoperation <br>Performance will be measured with:<br>• 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. <br>• Improvement in Oswestry Low Back Disability (ODI) of 15 or more at 24 months from the pre-operative value. <br>• Evidence of bridging trabecular bone between the involved motion segments.