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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02429908
Eligibility Criteria:
Inclusion Criteria:
* Age \> or = 18 years
* Degenerative disc disease DDD with up to Grade 1 spondylolisthesis or retrolis-thesis at the involved level. DDD is defined as discogenic back pain with degener-ation of the disc confirmed by history and radiographic studies.
* ODI 40 out of 100
* Back pain 4 out of 10
* Mono segmental or two level lumbosacral disease
* Skeletally mature patients
* Six months failed conservative treatment.
* Gave written consent to take part in the study by signing the Ethics Committee's approved Patient Informed Consent Form.
* Physically and mentally able to comply with the protocol, including ability to read and complete required forms and adhere to the follow-up requirements of the pro-tocol.
Exclusion Criteria:
* Prior surgical procedure at the index level(s) using the desired operative approach.
* Severe degenerative lesions at more than two level of the lumbosacral spine.
* Morbid obesity (BMI greater than or equal to 40).
* Active local infection in or near the operative region.
* Active systemic infection and/or disease.
* Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation.
* Known or suspected sensitivity to the implant materials.
* Endocrine or metabolic disorders known to affect osteogenesis (e.g.Paget's disease, renal osteodystrophy, hypothyroidism)
* Systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory or steroidal drugs.
* Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
* Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
* Pregnant.
* Unwilling to follow postoperative instructions, in particular with respect to athletic or occupational activities.
* Current vertebral metastatic tumors.
* Symptomatic cardiac disease.
* Severe congenital or acquired vertebral deformities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02429908
Study Brief:
Protocol Section:
NCT02429908