Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AOSpine North America Research Network
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis
