OsteoAdapt SP Spinal Fusion (OASIS) - Clinical Trial
What is the Purpose of this Study?
In this study, people are placed by chance into one of three groups. Each group uses different materials during spine surgery to help the bones heal and grow together. Two groups will use a material called OsteoAdapt SP with different amounts of a growth factor inside a small device placed between the bones. The third group will use standard bone materials taken from the patient or donated bone products. The study compares these groups to see which option helps the bones heal best after surgery.
The goal of this study is to see if a material called OsteoAdapt SP is safe and works well during certain spine surgeries. The study compares two different amounts of this material to a control group that does not receive it. The surgeries involve joining bones together in the lower back to help reduce pain and improve movement. Researchers want to learn if OsteoAdapt SP helps bones heal better during these procedures.
Who Can Participate in the Study?
People can join this study if they are 18 to 80 years old and fully grown. They must be planning to have a planned spine surgery for lower back problems, such as pain caused by worn out discs. They must have had this pain for a while and tried treatments like physical therapy or medicine for at least six months without enough relief. People must be healthy enough for surgery, have a certain level of back or leg pain, and be able to come to follow up visits.
People cannot join if they have had certain past spine surgeries in the same area, have weak bones such as severe osteoporosis, have infections, or use tobacco or certain medicines like steroids close to the time of surgery. They also cannot join if they have serious health problems, certain autoimmune diseases, active infections like HIV or hepatitis, or cancer within the past five years.
What is Involved?
The purpose of this study is to find out if a material called OsteoAdapt SP is safe and works well as a replacement for the usual bone graft used in certain spine surgeries. Researchers also want to learn which amount of OsteoAdapt SP works best so it can be studied in a larger study in the future.
Study Details
