Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01968993
Eligibility Criteria:
Inclusion Criteria:
* is at least 18 years of age and skeletally mature.
* must have symptomatic spinal stenosis and/or spondylolisthesis or degenerative disc disease (DDD) at one or two adjacent levels from L2-S1 requiring a fusion.
* must have completed a minimum of three months of unsuccessful conservative, non-operative care.
* must have discogenic back pain with or without leg pain.
* DDD must be confirmed by MRI or CT scans followed by discography (if necessary).
* must score at least 40% on the Oswestry Disability Index.
* must score at least a 4 on a 10 cm Visual Analog Scale for back pain.
* must be able to comply with the protocol's follow-up schedule.
* must understand and sign the informed consent document.
Exclusion Criteria:
* symptomatic at more than 2 levels.
* previous fusion surgery at any lumbar level with or without instrumentation (prior discectomy, laminotomy, laminectomy or nucleolysis at the operative (involved) level \> 6 months is permitted).
* more than 50% spondylolisthesis.
* lumbar scoliosis greater than 11 degrees.
* osteoporosis, osteopenia, osteomalacia, Paget's disease or metabolic bone disease.
* spinal tumors.
* active arachnoiditis.
* fractures of the epiphyseal plate or fractures for which stabilization of the fracture is not possible.
* impaired calcium metabolism.
* active infection or surgical site infection.
* rheumatoid arthritis or other autoimmune disease
* chronic steroid use (used steroids for one month within the last 6 months) or any medical condition that requires treatment with drugs known to interfere with bone healing.
* systemic disease such as AIDS, HIV, hepatitis (active), tuberculosis.
* morbid obesity defined as body mass index (BMI)\>40 or a weight more than 100lbs over ideal body weight.
* smokers unless the patient agrees to quit at least 2 weeks prior to and for the duration of the study, confirmed by a carboxyhemoglobin test prior to surgery.
* psychosocial disorders that would preclude accurate evaluation or has a history of substance abuse.
* active malignancy except non-melanoma skin cancer; history of any invasive malignancy unless treated and in remission for at least five years.
* documented allergies to porcine collagen or titanium
* pregnancy, or interested in becoming pregnant in the next four years.
* participation in another investigational study within 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01968993
Study Brief:
Protocol Section:
NCT01968993