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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT02564705
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 80 years, inclusive
* Grade I, II or III (less than 75% slip of the cephalad vertebra compared to the caudal vertebra) isthmic spondylolisthesis at single level between L4 and S1
* Unresponsive to a minimum of 3 months of non-surgical treatment
* No previous surgical treatment for isthmic spondylolisthesis
* Patients who are medically suitable for surgical management
* Patients who have consented for surgical treatment
* Willing and able to comply with the Investigational Protocol (IP)
* Informed Consent Form (ICF) signed by patient
Exclusion Criteria:
* Any previous lumbar spine surgery
* Patient has significant scoliosis (Cobb angle is greater than 25 degrees)
* Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction
* Subject is pregnant or of child-bearing potential and not currently on adequate birth control method
* Active infection at the surgical site
* Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the Investigator
* Pre-existent neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia
* Participation in another clinical trial of drug or device within the past 30 days that could influence the outcomes of this study
* Is a prisoner
* Acquired immune deficiency syndrome (AIDS) or AIDS-related complex
* Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated; patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02564705
Study Brief:
Protocol Section:
NCT02564705