you may be eligible to take part in a clinical trial for a new spinal fusion implant.
The OASIS Trial is evaluating a new spinal fusion implant called OsteoAdapt™ SP. The trial is assessing if the implant is safe and how well it works. It will also determine the best dosages of OsteoAdapt SP for future clinical trials.
Degenerative disc disease occurs when discs in your spine break down slowly over time. These discs normally act as cushions between the vertebrae, or bones, in your spine. As you age, the discs can wear down. This causes the bones to rub together and can result in back pain.
Spinal fusion is surgery to connect bones in the spine.Connecting the bones prevents movement, which helps to reduce or eliminate back pain.
During this surgery, the surgeon will remove a portion of the disc between two bones. Then they will insert a spinal fusion cage. The cage is hollow and needs to be filled to enable bone growth necessary for spinal fusion. A bone graft from you or a donor, or a synthetic graft, can be used to fill the cage. Over the next several months, the bones will heal together into one piece.
OsteoAdapt SP is an investigational new option for patients with degenerative disc disease. Based on results of preclinical studies, OsteoAdapt may be safer and more effective compared to approved spinal fusion grafts.
During surgery, OsteoAdapt is placed in the spinal fusion cage. OsteoAdapt contains a protein engineered to help bone grow. The protein is called AMP2.
OsteoAdapt is designed to avoid the challenges associated with bone grafts. It is a synthetic material. As a result, it eliminates the risk of disease transmission associated with donor bone grafts, as well as chronic pain that sometimes results from taking a graft from your own body. It is also believed to be more effective in promoting bone growth.
CAUTION: Investigational Device. Limited by Federal law to investigational use.
Surgeons: David Schwartz, MD; Craig McMains, MD
Study Coordinator: Melanie Glover, RN, BSN, MBA, CCRC
Contact: 317-802-2880 or mglover@orthoindy.com
Surgeon: David Weiner, MD
Study Coordinator: Joshua Lawrence
Contact: 301-877-4673 or joshua.lawrence@medstar.net
Surgeon: Cheng-Lun Soo, MD
Study Coordinator: Lupita Alvarez, MSBA
Contact: 405-676-5202 or lalvarez@okspinecenter.com
Surgeons: Paul Geibel, MD; Brandon Broome, MD
Study Coordinator: Veronica Gonzalez
Contact: 210-262-7651 or vgonzalez@nextstageclinical.com
Your surgeon will determine if you are eligible to be part of the OASIS Trial. You will be evaluated based on the following criteria. You may be eligible for the OASIS Trial if you:
Please refer to the list above to determine if there is a site near you.
Participants will be evaluated at regular times after surgery: at discharge, 6 weeks and 3, 6, 12 and 24 months. At these check-ups, you will be asked to complete questionnaires, forms, lab testing, X-rays and physical examinations.
The same check-ups are required regardless of which spinal fusion implant you receive in the study. You may receive compensation for study check-ups that are not part of routine spinal fusion care.
OsteoAdapt is a new treatment for spinal fusion that is only available to patients enrolled in this clinical study. Development of new treatments is impossible without patient participation in clinical trials. Your participation in this trial may provide potential benefits for you and others affected by degenerative disc disease in the future.
The OASIS Trial is randomized. This means that participants will receive spinal fusion with OsteoAdapt SP or a standard bone graft. Participants have a 2 to 1 chance of receiving spinal fusion with OsteoAdapt SP.
Participants may receive compensation for study check-ups that are not part of routine spinal fusion care.
Up to 80 patients will be enrolled in the trial.
The OASIS Trial is a first-in-human study. While OsteoAdapt has been studied extensively in preclinical trials, the study participants are the first people to receive OsteoAdapt SP.
AMP2 is a protein engineered to help bone grow. It is a next-generation version of bone morphogenetic protein (BMP). BMP is a naturally occurring human protein that stimulates the growth of new bone. While BMP has been used in many spinal fusion procedures, it has been associated with adverse events like inflammation and bone growth in unwanted areas. AMP2 has been designed to reduce these off-target effects.
AMP2 was shown to be safe in preclinical studies. Safety in humans is being studied in the OASIS Trial.
