CopiOs Posterolateral Fusion Procedure
Stopped early · Phase 2
Conditions studied: Spondylolisthesis, Stenosis
In brief
To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.
Key facts
- Study ID
- NCT01123850
- Run by
- Zimmer Biomet
- People needed
- 45
- Starts
- 2010-06-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2015-05-27
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Florida Hospital — Orlando, Florida, United States
- Neurological Surgery of Southern Illinois — Belleville, Illinois, United States
- Indiana Orthopedic Center — Indianapolis, Indiana, United States
- Las Cruces Orthopaedic Associates — Las Cruces, New Mexico, United States
- Upstate Bone and Joint Center — East Syracuse, New York, United States
- Scott and White Healthcare — Temple, Texas, United States
Full record on ClinicalTrials.gov
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