CopiOs Posterolateral Fusion Procedure
Spondylolisthesis, Stenosis
About this trial
This is an interventional treatment trial for Spondylolisthesis focused on measuring CopiOs, Degenerative spondylolisthesis,, stenosis with instability, or, degenerative disc disease as diagnosed by radicular signs and/or imaging studies
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.
Sites / Locations
- Florida Hospital
- Neurological Surgery of Southern Illinois
- Indiana Orthopedic Center
- Las Cruces Orthopaedic Associates
- Upstate Bone and Joint Center
- Scott and White Healthcare
Arms of the Study
Arm 1
Active Comparator
Single ARM - Copios Bone Filler
All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.