P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion
Condition: Degenerative disc disease
Key Inclusion Criteria
- Skeletally mature adults who are 22-80 years old
- Back pain with radicular symptoms as evidenced by leg pain
- Radiographically determined discogenic origin of the pain
Key Exclusion Criteria
- Systemic infection such as AIDS, HIV and active hepatitis
- Autoimmune disease that affects bone formation
- Significant metabolic disease that in the surgeon’s opinion might compromise bone growth
Full Study Name
An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation (IRB no. 55069)
This study focuses on individuals who have been diagnosed with degenerative disc disease (wearing out of the discs in the spine) and who have been referred for surgical treatment to fuse (connect) the bones surrounding the damaged disc because they have not responded to non-surgical treatments such as pain medication and physical therapy.
The purpose of the study is to determine whether the use of an experimental product, P-15L Bone Graft, is as effective at fusing bones surrounding the damaged disc as using the patient’s own bone (autograft) and possibly donor bone (allograft). It is believed that fusing the bones will help to relieve pain and loss of function. Using one’s own bone or donor bone is considered common practice for spine fusion surgery. Participants will be randomly assigned to one of two study groups. One group will use the P-15L Bone Graft, and the other will use their own bone (or donor bone).
P-15L Bone Graft contains calcium phosphate particles and P-15 in a carrier. Calcium phosphate is a mineral found in the bone; P-15 is a synthetic (man-made) segment of collagen.