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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT01461005
Eligibility Criteria:
Inclusion Criteria:
* Patient is skeletally mature (21-85 years old).
* Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
* Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
* Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.
Exclusion Criteria:
* The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
* Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
* Acute or chronic systemic, spinal or localized infections.
* Active, severe systemic and metabolic diseases.
* Obesity defined as Body Mass Index \> 35.
* Subject is pregnant or interested in becoming pregnant in the next 36 months.
* Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
* Lack of patient cooperation.
* Foreign body sensitivity to the implant material.
* Degenerative scoliosis greater than 25 degrees.
* Grade 4 degenerative spondylolisthesis (\>75% slip).
* Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required\*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
* Soft tissue deficit not allowing wound closure.
* Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
* Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
* Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
* Pars defect.
* Clinically compromised vertebral bodies at affected level due to current or past trauma.
* Prisoner or ward of the state.
* Currently in litigation regarding a spinal condition.
* Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
* Is currently involved in a study of another investigational product for similar purpose.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT01461005
Study Brief:
Protocol Section:
NCT01461005