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The Rational for Subchondroplasty

The Rational for Subchondroplasty

In a more recent understanding of the arthritic joint, science now tells us that it is not only loss of cartilage that leads to pain, loss of motion, altered function and a progressive downhill course; but rather an involvement of the entire joint as well as the bone supporting the joint. The mechanism is probably bio-immune in nature and the reason for our success in treating the arthritic joint with orthobiologics is based on addressing molecular changes within the joint. The Europeans however have taught us that almost as important as intervention inside the joint is addressing the bone supporting the joint. In a recent scientific meeting, Spanish and French Orthopedic Surgeons demonstrated improved overall results within the arthritic joint by treating the changes outside of the joint as seen in an MRI. These changes are frequently described as bone contusions or bone marrow lesions. When followed, it becomes apparent that the altered bone fails to support or protect the cartilage within the joint. By drilling into the subchondral bone, one stimulates a healing process and by adding orthobiologics, one hastens the healing of those bony lesions.

Subchondroplasty is accomplished with a specially designed drill bit and the orthobiologic is introduced through a specially designed trochar needle that slides over the drill bit serving additionally as a guide wire. The entire process is accomplished through a small skin puncture with accuracy enhanced through fluoroscopy, real time X-ray. Because the drill bit causes little structural damage, there are few alterations in the rehabilitation process when compared to the joint intervention alone. While Orthopedic Surgeons have been addressing these bony lesions by a macro system for several years with documented success, our work, as was seen on the Fox News airing last Thursday night, is based on minimally invasive means thereby eliminating the need for prolonged restriction of weight bearing and crutch dependency. Additionally, by introducing Bone Marrow Aspirate Concentrate in addition to the present Calcium Phosphate adjunct, the patient should anticipate healing in weeks, not months. The first target was the knee but we have expanded subchondroplasty to the ankle and soon to the hip and shoulder.

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The Rational for Subchondroplasty

The Subchondroplasty Procedure

You have presented with a painful joint and imaging is compatible with an arthritic process and/or a bone marrow lesion (contusion/bruise). Bone supports the joint and when damaged either by injury or as part of the arthritic process, contributes to pain and the progression of arthritis. The bone marrow lesion is seen on the MRI while the change of bone, subchondral sclerosis, is seen on the routine X-ray.

Patients with Bone Marrow Lesions are known to have increased pain, less function, faster joint cartilage destruction and reduced benefits from present forms of intervention. By addressing not only the arthritis but the bone surrounding the joint, it is anticipated that the results of intervention for the arthritic or injured joint will be markedly improved.

Subchondroplasty is a minimally invasive procedure targeting and treating subchondral defects that is the altered bone adjacent to and responsible for supporting the joint. During the treatment phase of injecting Bone Marrow Aspirate Concentrate for the arthritic joint, the subchondroplasty adjunct is completed under the fluoroscope. In conjunction with delivering the BMAC into the joint itself, additional Bone Marrow Aspirate Concentrate is placed into the surrounding bone through small drill holes created with a special canula. Up until now, the subchondroplasty drill holes were filled with a synthetic substance manufactured from Calcium Phosphate. The theory was that the Calcium Phosphate granules when placed into the bone defect would eventually be resorbed and replaced by bone. Using Bone Marrow Aspirate Concentrate is a much more physiologic stimulus for effecting bone healing in a much shorter time and by a means that more closely approximates bone healing after injury.

Our goal is to assist the patient in delaying or possibly avoiding a joint replacement through Regenerative Medicine (Cellular Orthopedic) approaches. The Bone Marrow Aspirate Concentrate intervention has proven extremely successful in meeting those goals. The introduction of Subchondroplasty will allow us to offer the possibility of increasing the success rate and the longevity of effect in appropriate settings and in any joint; hip, knee, ankle or shoulder.

 

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The Rational for Subchondroplasty

Complications of Arthroscopic Labral Repairs

In both the shoulder and the hip, there is a structure called the Labrum that since the introduction of the MRI and the arthroscope, has received exponential surgical attention. In the hip, the acetabular labrum is a ring of cartilage that surrounds the socket of the hip joint. Its function is to deepen the acetabulum and make it more difficult for the head of the femur to slip out of place. At the shoulder, the Glenoid Labrum is soft fibrous tissue that surrounds the socket to help stabilize the joint. Injuries to either structure may occur from acute trauma, repetitive impingement or as part of the degenerative osteoarthritic process. Symptoms of a tear in either location include pain, may be mechanical in nature (catching, locking, popping, or grinding), a decreased range of motion and loss of strength.

Herein is the diagnostic and therapeutic dilemma; does the orthopedist address the history and physical examination, the results of imaging, all of the above or some of the above? On the one hand, it has been clearly established both at the shoulder and at the hip, labral injury as demonstrated on the MRI or CT arthrogram may not be the source of the pain. If the problem is pain and there are arthritic changes in the joint, the results of arthroscopic surgery are poor. Even when there are mechanical symptoms such as catching, locking, grinding and popping, arthroscopic clean outs do not succeed in the presence of arthritis. When it comes to the shoulder, the arthroscopic attempt at repair of the labrum as part of the rotator cuff injury has only a 50% success rate. Even when done correctly, poor patient selection and complications can be devastating resulting in injury to cartilage, injury to bone, and chronic irritation of the joint lining.

Assume if you will that a 45 to 55 year old or even older patient presents with pain in the shoulder or hip. The MRI is interpreted as compatible with a labral tear. There is an option which may very well eliminate the pain and affect healing of the torn structure, Bone Marrow Aspirate Concentrate followed by physical therapy. The procedure is done with a needle and not a scalpel; the complication rate in my experience is extremely low and the success rate extremely high. Let me cite an example of a patient who presented at age 67 with bilateral chronic shoulder pain for which he had undergone multiple prior attempts at arthroscopic surgical remedy. Four months after having undergone bilateral Bone Marrow Aspirate Concentrate Stem Cell intervention, he is off his chronic opiate containing pain medication and playing golf while having returned to his unlimited fitness routine. This is only one success story, there are many more. If you want to learn more about the potential options for your painful shoulder or hip, call for a consultation:

847 390 7666

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The Rational for Subchondroplasty

Orthopedic Surgery through a Syringe

That’s the headlines in several orthopedic articles recently appearing in scientific journals and that’s what is predicted for the future. I have been using that syringe in lieu of a scalpel for three years. Four years ago, it was a four-inch incision for a knee and a ten-inch incision for a hip. A revision required more than double that length with major muscle disruption of life and a marginally successful outcome.

Let’s return to the alternative for a joint replacement in an arthritic joint, Bone Marrow Aspirate Concentrate. This past weekend, I presented the 12 to 24 month outcomes of Bone Marrow Aspirate Concentrate for knee arthritis in 172 patients I have treated, at the Orthopedic and Biological Institute 5th annual meeting held in Las Vegas. More than 500 physicians from around the world attended it. The paper was very well received as indicated by a continual flow of e-mail commentary, and will influence how the attendees approach osteoarthritis in their respective patient populations in the immediate future. While I educated the audience, I also learned something from several French and Spanish Orthopedists speaking at the meeting. In addition to treating the arthritic joint, three studies were delivered in which the bone immediately adjacent to the arthritic joint was injected with stem cells in addition to placing BMAC in the joint itself. Called a subchondroplasty, it adds little extra to the procedure and to date, seems to have significantly improved results. As of July 1, the modified approach will be included in my treatment protocol for the osteoarthritic knee when I deem appropriate. It takes a team and a lot of time and effort to complete these outcome studies. That’s why most clinicians don’t partake. At most, some do it by telephone or forms to be completed by the patient and mailed in. That’s not the way of a joint replacement surgeon. Our outcome scoring is objective and includes hard end points such as reproducible measurements. My having incorporated clinical research into my patient care efforts has resulted in a continual improvement with better and longer lasting outcomes in my management alternatives for arthritis. I have the data to prove it.

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What’s next in Regenerative Medicine; will Amniotic Fluid Concentrate replace Hyaluronic Acid injections?

We are always learning from Data and in this Blog, I will let you learn with me. Please note that the results reproduced below are very preliminary and not to confused with the indications or results of our Bone Marrow Aspirate Concentrate/Stem cell interventions and outcomes. Because of the American Academy of Orthopedic withdrawal of support for visco-supplementaion (Hyaluronic Acid)in the arthritic knee, the orthopedic world is seeking something to fill that void, hence the interest in Amniotic Fluid Concentrate. Cortisone injections expanded with local anesthetics has been the mainstay but recent data indicates that local anesthetics kill cartilage and several cortisone injections are equally toxic to cartilage in animal models.

Interim Analysis of Prospective, Multi-Center Outcome Observational Cohort Registry of Amniotic Fluid Treatment for Osteoarthritis of the Knee Douglas Beall, MD,* Sri Nalamachu MD, **

Introduction Osteoarthritis (OA) of the knee is one of the leading causes of functional limitations and poor quality of life. Nonsurgical treatment of OA of knee includes oral medications and injection. Corticosteroid or hyaluronic acid (HA) injections to alleviate pain and/or improve function are common techniques but recently HA effectiveness has been questioned for the treatment of OA of knee in the Medicare population as well as for its overall efficacy. Alternatives are sought to provide pain relief and improve functional outcomes. Allograft amniotic tissues have a long history of clinical use. The use of amniotic fluid in the treatment of knee OA was initially reported by Shimberg  who demonstrated that injections of the fluid improved knee function and pain relief without any significant adverse events in 68 patients. Amniotic fluid is a homologue to synovial fluid which acts as a cushion to protect and lubricate the contents in a closed environment. This study measures the safety and efficacy of processed allograft amniotic fluid in treating osteoarthritic knees using common, validated instruments.

Summary of methods This is a protocol-driven, single arm post-market Registry reviewed and approved by the Western Institutional Review Board (Olympia, WA). Patients with Kellgren Lawrence Grade 1-3 OA via radiologic examination were eligible for enrollment. Excluded patients were < 35 years, had BMI > 45 or had received Hyaluronic Acid injections in the previous six months, or steroid or PRP injection in the last three months. There were no threshold pain inclusion or exclusion criteria. Eligible patients were injected with 4cc of minimally processed amniotic fluid (AmnioClear LCT; Liventa Bioscience, West Conshohocken, PA) into the affected knee. Primary efficacy endpoints are VAS scores and WOMAC overall and Pain, Stiffness and Difficulty (function) subscore scales, measured during office visits at baseline and at 30, 90 and 180 days. Enrollees also filled out weekly Pain Diaries to report WOMAC Pain subscore (5 questions) at weeks 1-4 post-treatment. Results To date over 420 of an anticipated 470 Registry enrollees have been treated. This is an interim analysis of the first 181 patients to attain 30 day follow up and the first 51 to attain 90 day follow up visits, with 15 of 23 investigational sites reporting. WOMAC Pain subscore average improvement over baseline was 62.1 percent (150.9 mm) and 62.3 percent (151.2 mm), respectively at 30 days and at 90 days. VAS average improvement over baseline was 58.9 percent (37.7mm) and 62.5 percent (40 mm) at 30 and 90 days, respectively. All other WOMAC scores showed similar improvement.

OMEGA Statistics, Murieta, CA On average, patient outcomes improved significantly compared to basel

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