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:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01123850
Eligibility Criteria:
Inclusion Criteria:
* Patient must be skeletally mature; between the ages of 21 and 75
* Patients having degenerative spondylolisthesis, stenosis with instability, or degenerative disc disease as diagnosed by radicular signs and/or imaging studies
* Patients will be medically indicated for a single-level, instrumented PLF between L2 and S1 per their surgeon
* Patient must be willing and able to comply with study requirements, including all necessary study related paperwork and follow-up visits
Exclusion Criteria:
* Use of iliac crest bone graft;
* Any previous lumbar spinal surgeries at indicated level;
* Any medical or physical condition that would preclude the potential benefit of spinal surgery;
* Use of a dynamic stabilization systems;
* Sites where stresses on void will exceed the load strength of fixation of hardware;
* Segmental defects;
* Significantly impaired vascularity proximal to the surgical site;
* Sites in direct contact with articular space;
* Soft tissue deficit not allowing closure;
* Active systemic or local infection;
* Severe degenerative bone disease;
* Patients with osteoporosis who are actively under treatment;
* Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI\>40 kg/m2);
* Active malignancy;
* Patients with a history of multiple allergies;
* Patients with known allergies to bovine collagen;
* Hypercalcemia;
* Pregnancy;
* Mental illness;
* Alcohol or drug abuse;
* Incarceration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT01123850
Study Brief:
Protocol Section:
NCT01123850