Biologic treatments in orthopedics are gaining attention as options for patients. Four physicians shared the most promising areas of regenerative medicine for the specialty.
Ask Orthopedic Surgeons is a weekly series of questions posed to surgeons around the country about clinical, business and policy issues affecting orthopedic care. We invite all orthopedic surgeon and specialist responses.
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Editor's note: Responses were lightly edited for clarity and length.
Question: What area of regenerative medicine holds the biggest promise for orthopedics?
Niranjan Kavadi, MD. A surgeon in Oklahoma City: Orthobiologic therapies hold the biggest promise in the field of orthopedics. Orthopedic surgeons commonly see patients with painful conditions where the evidence for surgical treatments to offer predictably good outcomes is variable. As providers, the inability to offer definitive solutions for patients with conditions such as mild degenerative disc disease or knee pain in a younger individual without radiographic changes can be quite frustrating. This is where biologics like platelet-rich-plasma and bone marrow aspirate concentrate would be quite helpful. The products are relatively easier to obtain and much less expensive than synthetic products. The treatment regimens will change significantly if good results can be obtained with the use of these therapies consistently. However, at this time the evidence in support of these is limited and caution should be exercised in their adoption as well as managing patient expectations.
Scott Sigman, MD. OrthoLazer Orthopedic Laser Centers (Rochester, N.Y.): The literature support for regenerative medicine is growing every day. Groups such as the International Orthobiologics Foundation, The Orthobiologic Institute and the Biologic Association continue to produce quality data on the positive outcomes associated with orthobiologics. Despite the extensive body of support and improved patient outcomes, orthobiologics remains a patient pay model. In order for orthobiologics to become mainstream, reimbursement will have to cross over to commercial and CMS payment. The issue is the arduous process required to gain FDA approval for a specific diagnosis to gain a CPT code. It will be difficult for homologous patient treatment options to cross over that chasm. The more likely successful model to gain insurance reimbursement will be through pharma companies who have the infrastructure and financial support to generate the required RCTs to achieve widespread use.
Wasik Ashraf, DO. Crystal Run Healthcare (Monroe, N.Y): The future of orthopedics lies in making sure that mechanical healing and biological healing work together. Technologies like Tactoset injectable bone substitute for hardware augmentation don’t disrupt the biologic environment, allowing joints to recover from procedures efficiently. Patients prefer a minimally invasive procedure that allows pain relief and increased range of motion so they can get back to their activities quickly. Tactoset provides a minimally invasive treatment option for bone marrow lesions or insufficiency fractures that once injected, hardens to mimic the properties of normal trabecular bone initially, remodeling into healthy bone over time. The new indication expands the use of Tactoset to include augmentation of hardware and the support of bone fragments during surgical procedures.
Bruce Werber, DPM. An orthopedic consultant in Miami: Considering the current state of the art and science, it is my belief that placental-based cellular and acellular derived regenerative therapeutics hold the biggest promise in the orthopedic specialties. Allografts derived from placental tissues offer a wide spectrum of regenerative components in appropriate concentrations. Consider that the donor mother has been screened for a healthy lifestyle, medical and family history are without issue, extensive serology to ensure no bioburden in mothers or fetal systems and lastly a healthy baby has been born. The birth tissues from these consented donor mothers are collected at the time of elective C-section, tested extensively and processed to provide a wide spectrum of microRNA, full spectrum of growth factors, and peptides. Pluripotential MSCs are also available in these tissues, as the research grows and clinical trials are instituted and completed we will find tremendous potency and safety utilizing both cellular derived therapeutics and well as the Exosome derived therapeutics to significantly accelerate bone, tendon, fascial and soft tissue wounds and injuries without adverse events. The incidence of postoperative infections, delayed or non-unions will decrease, prolonged pain swelling and scarring will be diminished markedly.
Currently the literature has a plethora of case series supporting my point of view; the industry needs to complete the appropriate clinical trials to bring the power and safety of placental derived therapeutics to mainstream orthopedics and medicine.