Michael Hasz, MD, FACS, is a spine surgeon at The Virginia Spine Institute in Reston and was among the first spine surgeons to perform an artificial disc replacement as part of a Food and Drug Administration trial approximately 10 years ago. Now, the Synthes ProDisc is approved for market use but it is still a foreign procedure for many surgeons around the country. Dr. Hasz discusses five points on performing the artificial disc replacements and what's in store for the procedure over the next few years.
1. Appropriate indications for artificial disc replacements. Not all patients will benefit from artificial disc replacements, and it is important for surgeons to recommend the appropriate patients for this procedure. "It makes a huge difference for patients with the right indications and expectations," says Dr. Hasz. "The people who benefit from artificial discs currently are those with one-level disc disease who have failed non-operative treatment."
Patients usually undergo three to six months of physical therapy and receive epidural injections before resorting to surgical intervention. To qualify for artificial disc replacement, a surgeon must identify the disc as the source of the patient's pain. The patient can't have arthritis, osteoporosis, spondylolisthesis or any other condition that might cause unsteadiness in the spine. "As long as they don't have any gross instability, we will be able to perform the artificial disc replacement that allows patients to maintain motion in their backs," he says.
2. Performing the procedure. The artificial disc replacement using ProDisc is a minimally invasive anterior procedure where the surgeon makes a small incision along the bikini line. The surgeon works through the front of the patient's body to access the spine without disrupting any muscle. "This approach allows surgeons to go through a tissue plane they can dissect easily to access the spine," says Dr. Hasz. "We then use small retractors so we can see the area we want to see. With less disruption, the patient is often able to go home the day after surgery."
Once the surgeon has access to the disc space, the damaged disc is removed and the disc space is mobilized and. The surgeon uses an X-ray while inserting the artificial disc to make sure it's placed in the correct spot. Surgeons must be more precise in the artificial disc replacement procedure than with fusions because if the disc is slightly misplaced, it could cause major complications for the patient.
"You want to have the artificial disc in the right position so the spine will pivot correctly," he says. "The ProDisc is designed to be motion preserving; not to provide more motion than the patient had before. In theory, it will protect the spine above and below the artificial disc because the back will be allowed the same range of motion as before. There has been a lot of work done to create a disc that moves as similarly to the normal disc as possible."
3. Insurance coverage for the procedure. Even though insurance companies don't reimburse well for the disc replacement, there are several cost-saving factors to the procedure that may encourage broader coverage in the future. For example, patients undergoing conservative treatment without good results may spend several months receiving the same treatment when they might benefit from a one-time surgical procedure that would cost less in the long run.
"Some insurance companies are refusing to allow surgical intervention for patients with back pain, but in the big picture, it may cost them less," says Dr. Hasz. "We have to fight some companies for coverage by showing them the science behind what we are doing. There are some companies that have thought it through and are approving the procedure as a first choice for appropriate patients after conservative treatment."
4. Where artificial disc replacement research is headed. It will be important for spine surgeons to collect all the data necessary to make the appropriate diagnosis for patients who could benefit from artificial disc replacement before performing the procedure. Once the best outcome indications are set, researchers can focus on progressing the design of the implant to incorporate patients who need multi-level surgical interventions. The big factor prohibiting surgeons from conducting studies to prove the effectiveness of multi-level artificial disc replacements is the cost associated with the FDA clinical trials, says Dr. Hasz.
"The big keys right now are demonstrating that in the right person these discs are life-changing so we can have the opportunity to treat patients with more than one-level disc disease," he says. "It's going to require a lot of patient involvement so that we can fight for their opportunity to have access to this current technology, which really isn't in the experimental stages anymore."
5. What to look for further in the future. In the long term, surgeons may be able to find a different way to access the disc space where even less tissue is disturbed. This may include using a lateral instead of anterior approach. Surgeons will continue to gather information about the current procedure and look for new ways to make the procedure better.
"There is more and more information out there about artificial disc replacements and as we collect more data, more innovation will be possible," he says. "It's very important we continue collecting data because all surgeons want to do the right thing. The only way we know whether our surgeries are working is by following up with our patients."
Learn more about Dr. Michael Hasz.
Related Articles on Spine Surgery:
6 Techniques for Building a Successful Spine Practice
5 Points on Spine Patient Advocacy
Adolescent Scoliosis Treatment Challenges and Innovations: Q&A With Dr. Christopher R. Good of Virginia Spine Institute
Patients usually undergo three to six months of physical therapy and receive epidural injections before resorting to surgical intervention. To qualify for artificial disc replacement, a surgeon must identify the disc as the source of the patient's pain. The patient can't have arthritis, osteoporosis, spondylolisthesis or any other condition that might cause unsteadiness in the spine. "As long as they don't have any gross instability, we will be able to perform the artificial disc replacement that allows patients to maintain motion in their backs," he says.
2. Performing the procedure. The artificial disc replacement using ProDisc is a minimally invasive anterior procedure where the surgeon makes a small incision along the bikini line. The surgeon works through the front of the patient's body to access the spine without disrupting any muscle. "This approach allows surgeons to go through a tissue plane they can dissect easily to access the spine," says Dr. Hasz. "We then use small retractors so we can see the area we want to see. With less disruption, the patient is often able to go home the day after surgery."
Once the surgeon has access to the disc space, the damaged disc is removed and the disc space is mobilized and. The surgeon uses an X-ray while inserting the artificial disc to make sure it's placed in the correct spot. Surgeons must be more precise in the artificial disc replacement procedure than with fusions because if the disc is slightly misplaced, it could cause major complications for the patient.
"You want to have the artificial disc in the right position so the spine will pivot correctly," he says. "The ProDisc is designed to be motion preserving; not to provide more motion than the patient had before. In theory, it will protect the spine above and below the artificial disc because the back will be allowed the same range of motion as before. There has been a lot of work done to create a disc that moves as similarly to the normal disc as possible."
3. Insurance coverage for the procedure. Even though insurance companies don't reimburse well for the disc replacement, there are several cost-saving factors to the procedure that may encourage broader coverage in the future. For example, patients undergoing conservative treatment without good results may spend several months receiving the same treatment when they might benefit from a one-time surgical procedure that would cost less in the long run.
"Some insurance companies are refusing to allow surgical intervention for patients with back pain, but in the big picture, it may cost them less," says Dr. Hasz. "We have to fight some companies for coverage by showing them the science behind what we are doing. There are some companies that have thought it through and are approving the procedure as a first choice for appropriate patients after conservative treatment."
4. Where artificial disc replacement research is headed. It will be important for spine surgeons to collect all the data necessary to make the appropriate diagnosis for patients who could benefit from artificial disc replacement before performing the procedure. Once the best outcome indications are set, researchers can focus on progressing the design of the implant to incorporate patients who need multi-level surgical interventions. The big factor prohibiting surgeons from conducting studies to prove the effectiveness of multi-level artificial disc replacements is the cost associated with the FDA clinical trials, says Dr. Hasz.
"The big keys right now are demonstrating that in the right person these discs are life-changing so we can have the opportunity to treat patients with more than one-level disc disease," he says. "It's going to require a lot of patient involvement so that we can fight for their opportunity to have access to this current technology, which really isn't in the experimental stages anymore."
5. What to look for further in the future. In the long term, surgeons may be able to find a different way to access the disc space where even less tissue is disturbed. This may include using a lateral instead of anterior approach. Surgeons will continue to gather information about the current procedure and look for new ways to make the procedure better.
"There is more and more information out there about artificial disc replacements and as we collect more data, more innovation will be possible," he says. "It's very important we continue collecting data because all surgeons want to do the right thing. The only way we know whether our surgeries are working is by following up with our patients."
Learn more about Dr. Michael Hasz.
Related Articles on Spine Surgery:
6 Techniques for Building a Successful Spine Practice
5 Points on Spine Patient Advocacy
Adolescent Scoliosis Treatment Challenges and Innovations: Q&A With Dr. Christopher R. Good of Virginia Spine Institute