What questions should you ask?
In the world of regenerative medicine, not all procedures are created equal. A lot of healthcare professionals claim to provide regenerative medicine procedures, so it is important you are an informed consumer to avoid wasting time and money on ineffective procedures. Worse, this could lead you to believe this medical technology “doesn’t work,” when it just wasn’t performed up to the industry standard.
This begs the question of: How do I know what makes a quality regenerative procedure? So, we have compiled the Top 10 questions to ask when considering a regenerative medicine procedure.
If any of these questions do not have answers that match our descriptions, the clinic is not operating within the industry gold-standard and you should consider shopping around more. At Regenexx at New Regeneration Orthopedics (NRO), it is our promise to you that the following are the code of excellence we abide by to ensure the best possible outcome to your regenerative procedure.
In this two-part series we will address the following topics to ensure you are an informed consumer of regenerative medicine: Physician Experience, Patient Outcomes, Physician Specialty, Source of Injectate, Injectate Harvest Methods, Laboratory Procedures, Dosage or Concentration of Platelet or Bone Marrow Concentrate cells, Injectate Placement Procedure, Contraindications for a Procedure, and Candidacy for a Procedure.
How Many Regenerative Procedures Have You Done?
Experience is everything. It is important to understand how many procedures a physician has done, or how long they have been performing regenerative injections. If this is an add-on occasional procedure a physician does, or if this is a nurse practitioner within a chiropractor’s office, their experience pales in comparison to the physicians at NRO. Our physicians exclusively perform orthopedic regenerative procedures and have practiced this style of non-operative orthopedic medicine exclusively for years. For reference, Dr. Leiber wrote previously on this topic and defined experience:
The more a physician has successfully performed a procedure, the better the outcome and the fewer complications. For surgical procedures, a surgeon typically considers themselves an expert once they have done a procedure two hundred times or more.
Our NRO Physicians have done thousands of regenerative medicine procedures. In fact, as a practice the NRO physicians help the most patients in the entire Regenexx network per calendar year.
The takeaway: Ask specifically how many regerenative procedures they have completed.
What Outcome Data Do You Collect and Report?
It is important that any physician group performing a large number of common procedures report their outcomes in a registry. The registry is a collection of patient-reported outcomes at various intervals after their procedure. The patients answer questions related to their perceived pain levels and function as compared to before the procedure. Then, this data is published in a registry that is organized per body region and is available to the public.
Since no procedure or surgery out there has a 100% success-rate, the registry data is a transparent look into the efficacy of regenerative procedures per body region. Not only is this important for physicians to review when learning what new technology and techniques are growing the realm of orthopedic medicine, but patients can review what patients like them reported their outcomes to be. For example, for a patient interested in a regenerative procedure for their low back, there are (as of September 2022’s registry) 11,176 reported lumbar spine procedures. The patients reported their overall improvement as well as improvements in pain and function over time intervals ranging from one month post-procedure to four years post procedure.
Please ensure the practice you are working with has the ability to tell you data about their outcomes, success rate, and even complications.
The takeaway: Ask if they have a registry of outcomes or any publications in medical journals regarding their specific style of treatment.
What is Your Medical Specialty and Training?
The non-negotiable for the speciality/training category is concerning if the procedure is image-guided. All of our physicians are trained in both a diagnostic ultrasound and live fluoroscopic x-ray that are imperative in visualizing the area being injected. The procedures are dependent on the precise placement of the platelet or bone marrow cells, so if a clinician suggests a “blind” injection that isn’t image-guided, that is not the right fit.
Additionally, all of our providers at NRO are Board-certified physicians specializing in sports medicine, physical medicine, or interventional pain treatment, and are trained to perform injection-based care for joints. Physician speciality matters, and is important to know about the physician planning to perform your regenerative procedure.
The takeaway: Ask what training the provider has in image-guided injections.
What Types of Tissues or Cells are Used in Your Regenerative Procedures?
Not all cells are created equally. Many clinics performing regenerative procedures source the regenerative cells from a manufacturer. The products from manufacturers are marketed as more potent, coming from a source that is fresher than the patient’s own cells, since many patients may be of advanced age. However, this couldn’t be farther from the truth. Research studies demonstrate that mesenchymal cells are the most effective for orthopedic repair, including cartilage and tendon tissue.
Be sure to ask your doctor where the source of the regenerative cells comes from. If they are not autologous, or from the patient’s own blood or bone marrow, then it is not in alignment with the latest clinical research.
The takeaway: Ask the provider where they harvest cells or tissues from and what type of product they use.
How Do You Harvest the Tissues Used in Your Procedures?
The cell harvesting method is critical. The techniques vary for the extraction, depending on the source. For a platelet rich plasma procedure (PRP), the blood is harvested from a simple blood draw. This is then processed in to the PRP product for the procedure.
For a bone marrow concentrate procedure (BMAC), the bone marrow is extracted from the iliac crest in the pelvis. A great deal of experience and image guidance is necessary to perform a bone marrow aspiration; otherwise, there is a significant risk the physician will aspirate blood without stem cells, instead of bone marrow cells. Additionally, the physician should be extracting the bone marrow from multiple sites to ensure the best volume of cells extracted. Then, the bone marrow is processed in a sterile laboratory, where the mesenchymal cells are extracted from the bone marrow.
The takeaway: Ask the provider how many bone marrow aspirations they have performed, if they use imaging, and how many sites they extract from.
These are the first 5 of 10 total questions we recommend asking when pursuing a regenerative procedure. If the answers deviate from the evidence-based sources, methods, and provider training we suggest here, we would love to connect with you at Regenexx at New Regeneration Orthopedics to see if we are a fit for your orthopedic needs. Tune in next week for questions six through ten, so you can ensure you are fully prepared to advocate for yourself as a patient and get the best regenerative procedure for your condition.
Have more questions? Feel free to ask any of our physicians.