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How FDA Studies can help you with back and neck pain.

It takes more than study and perfection to make motion preservation better for all patients.

 

At least one of the reasons I work hard as a physician in the field of spinal disorders and motion preservation surgeries is because of my personal experience as a patient. I’ve had eight back and neck surgeries over 15 years, and I am driven to understand more about the surgeries and therapies I prescribe to my patients.

 

Of course, most of my patients only have one or two surgeries over the same period. That’s because most of my patients have spines that are in a lot better condition than mine. I’ve had two spinal fusions and five artificial discs to help me keep moving. Naturally, I’m interested in learning as much as I can about what else I can do for my patients and myself. I’ve become an enthusiastic advocate for artificial disc replacement surgery. And I also work on clinical research to help develop new artificial discs and supportive surgical procedures.

 

I have been fortunate enough to be selected as a principal investigator for several groundbreaking studies that have helped new implants gain FDA approval. The latest of these studies was completed more than a year ago on the M6-C artificial cervical disc. It’s a new disc design that I believe does a better job of mimicking the motion dynamics of natural spinal discs. FDA approval was finally granted earlier this month.

 

As a principal investigator, I fill a unique role in the medical research and clinical study process that is often the last stage before full FDA approval. Medical device companies depend on principal investigators to help them go the final mile before approval. They depend on experienced surgeons like me to manage the research process, ensure integrity in the study, compile data, and produce a final report. I’ve seen hundreds of patients at my practice in Beverly Hills, CA. But they also benefit from my work as an associate professor at the UCLA Department of Neurosurgery and my long association as faculty at Cedar-Sinai Medical Center in Los Angeles.

 

In my capacity as a medical researcher, my goal is to ensure that the device is safe and effective for the purpose it was intended in a real-world patient application. In a very literal sense, you could say that my neck is on the line as well as those of thousands of my fellow patients on the accuracy and viability of such studies. But it’s my patient advocacy that many of my colleagues remember. When it comes to real-world applications and patient treatment plans, we can always do better.

 

But my study isn’t only about medical procedures and the latest technology.

 

Another result of my work is realizing the benefit of time. I make every encounter I have with my patents a mindful act to uncover and treat spinal disorders. I have found that the more time I spend with a patient, the better the chances for a positive outcome. And the most favorable outcome of all is the preservation of motion.

 

Such positive outcomes, however, take a lot of work.

 

Several years ago, a patient came to me for a second opinion. The first thing that surprised him was that my initial consultation took nearly an hour. We spent a great deal of time talking about his activities and his work as a coach for a local university. Some of the conversation delved into personal fears he had about back surgery and what it might represent in terms of loss of motion and degradation of his lifestyle. He waited for as long as he could, tolerated the pain and discomfort because he was sure that surgery meant that his old life was over.

 

“The other guy spent 15 minutes with me to confirm my worst fears,” he said. The previous surgeon had recommended a two-level cervical fusion. “You spent one hour with me and restored my hope.” My recommendation was a two-level artificial disc replacement.

 

As he was leaving my office, he turned around with an expression that told me he was turning a corner. “When will I feel better?” he asked.

 

I didn’t even think about my answer because it was right there at the front of my mind. “You’re not going to be just better my friend. You’re going to be greater than better.”

 

My patient didn’t need more words. He didn’t need more evidence and medical data. He didn’t even expect a specific date when anything was going to happen. He understood what I meant by being “greater than better.” It meant that the chronic pain would be gone and he was going to surpass his surgery and be fully restored.