Genesis Orthopedic Research
The following 3 projects are currently under way:
- Osteoporosis and fragility fractures:
One of two Caucasian women and one of three Caucasian men will have an osteoporosis-related fracture in their lifetime. This includes fractures of the hip, spine, and wrist. After someone suffers a fragility fracture, they are often, never the same. Twenty percent of elderly after a hip fracture die in the first year after their injury. Many continue to have pain and limp. Many lose their independence. Many people because of weak bone have more fractures. The best method is to prevent these fractures by improving bone quality. The problem is not just that they are falling; the real problem is their weak bone.
The National Osteoporosis Foundation along with many other international committees has established accepted guidelines for bone health. Unfortunately most studies have shown that these guidelines are NOT followed. Worldwide, only about 20% of patients after fractures get evaluation and treatment. And so, the epidemic continues.
We plan to study a method that will change the current system to create better evaluation and treatment. The study would be prospective, blinded and randomized. We plan to enter a total of 300 patients into the study. There are a few examples of successful programs. One such program, a leader in the world is at Kaiser Permanente in Southern California. They have managed to reduce fragility fractures by over 40% per year. Using that example, for Shaare Zedek, this would mean instead of 600 fragility fractures per year, there would be 240 LESS per year or 20 less per month. This is 20 less injuries EVERY month for our parents and grandparents with life-altering injuries, many of which would cause death, or permanent disability and pain.
- Tennis Elbow:
Tennis elbow is a painful condition. The pain, which can be severe, occurs with almost any use of the hand but especially with gripping. This condition affects people worldwide. Although many researchers have studied tennis elbow, with literally hundreds of articles published, no treatment other than surgery has proven to be effective. Traditional treatment has included physical therapy and anti-inflammatory medications. Other treatment options can include forearm straps, wrist braces, and acupuncture. None of these have proven to be helpful. People will often say that their tennis elbow improved with treatment. Research has shown that when you compare two groups, the same percentage of people improve with or without injection. Injection with cortisone is the most common treatment but many studies have shown that relief is temporary, lasting on average only 6 weeks. More recently, some researchers have tried injecting the patients’ own blood products, such as PRP (platelet rich plasma). Besides being costly and requiring the taking of blood, the results are variable and few studies have shown that it really works.
The (annual) incidence of tennis elbow is 1-2% per year. Assuming a US population of 400 million, and only 1% incidence, this means that as many as 4 million people might have some degree of tennis elbow.
We plan to study a material that currently is used for other medical conditions but has shown great promise in curing tennis elbow. I have personally been injecting this medication for 2 years and have about 85% success rate. In this project, we will perform a scientific study to prove that it works. We will test 3 groups of people, prospectively with either one or the other formulation of this medication against a control group. The project will take one year and another year to get final follow-up.
- Total Elbow Registry
A registry is a database that contains ongoing data about surgeries or conditions. In the United States and around the world, there are registries for different diseases and also for joint replacements. Specifically, patients that undergo hip and knee replacement are often included in these databases. This allows researchers to later determine for example which implants work the best or to determine the complication rate and how to improve it.
The registry has many advantages. Understanding success and failure will allow surgeons and patients to make better choices. Unlike a research study that might take years to perform, a database provides continuous information. It would be the difference between driving with your eyes closed and checking every few minutes to see if you are going in the right direction or driving with your eyes open to get continuous feedback. Not all research is appropriate for database management. The study here is ideal since it is an accepted treatment but it would normally take years and many studies to see how the results of our treatment are performing. A database gives us that information much sooner and as more patients get treatment and enter the database, there is more and more information to evaluate and the conclusions get stronger.
Orthopedic registries in other countries have seen up to 50% reduction in revision rates after identification of best practices. Registries provide information that allows data to drive decisions.
Currently, Israel has NO registry for joint replacement. We propose to start a registry for total elbow replacement. We chose elbow replacement since there are only about 10 surgeons in all Israel who perform this specialized surgery. This will allow us to contact and enroll each surgeon and thus capture all cases of elbow arthroplasty in an entire country. Once the database is running, we can add our database to other countries and get more information from those countries as well as contribute to the world database.
The following projects are in planning phase:
- Grip Study:
We know little about the strength needed for activities of daily living (ADL). Doctors often use motion in determining patient function and limitations. For example, doctors and therapists check motion after an injury or surgery to determine if the patient is making progress. Motion is also used to determine disability. People are often left weak after injuries and this information is not used. Weakness whether temporary or permanent often limits when people can return to work, and if permanent, can limit their activities for life.
This proposed study will test the strength needed to do activities needed to live a normal life. Therapists and doctors have devices that in the office can measure the strength of gripping and pinching. But, we do not know how that strength correlates with the needs to perform activities we do on a daily basis. For example, opening a jar may require 8 pounds of grip force. If a person can only generate 6 pounds, it would be almost impossible to open the jar. The hypothesis of this study is that many tasks required for normal activities have an inherent strength requirement. The purpose of this study is to take a carefully researched list of 15 activities that form a baseline for daily activities and measure the strength needed for each.
Scientists and clinicians can use this information in many ways. Injury, arthritis or surgery may leave a patient temporarily or permanently weakened. The information we will collect here may be used to help refine indications for surgery or determine if surgery was indeed successful. For example, thumb arthritis is a common problem that requires surgery. There are many methods available. Knowing the strength requirement and measuring the strength after surgery can help determine which surgery is the better one.
Other potential benefits may include product design that prevents minors but allows seniors to open packages. The method may be used in studying the effects in industry on tool handle design that lowers pinch requirements to reduce hand fatigue. Finally, the method may be useful in anthropological studies on strength requirements for early tool production or even used in primate studies on tool use.
- Taguchi Method of quality:
At MIT, I learned a statistical method where quality is designed into a project. As an engineering concept, we define quality as lack of variation; in other words, consistency. For example, when you buy a car, you don’t want the occasional “lemon”. When you fly in an airplane, you do not want the one where the wing is the rare weak wing that may fall off during flight. Unfortunately, in medicine, the concept of designing quality into a surgery or treatment does not really exist. This is because these methods are in the engineering world and medicine and engineering have separate knowledge bases. I am planning to use this Taguchi Method to test clinically the repair of cut flexor tendons in the hand. I did a project years ago (published in the Journal of Bone and Joint Surgery) that was a mechanical version. In this proposed study, we will use the method to improve clinical results in patients who have suffered a tendon laceration in their hands.