Frequently Asked Questions About CurPoint Orthopedic Seattle, WA
Please Give Us a Call at (206) 309-8106 If You Have Any Additional Questions.
What are my legal and ethical rights as a patient?
- You have the legal and ethical right to direct what happens to your body.
- You have the legal and ethical right to be informed about your condition/diagnosis
- You have the legal and ethical right to fully understand the recommended surgical, medical, or diagnostic procedure(s), so that you may give or withhold your consent.
What is Informed Consent?
Informed consent is a cornerstone of the physician-patient relationship. To be valid, it must involve a partnership, one where patients and doctors make decisions together. Your doctor has a responsibility to disclose the nature of the proposed treatment or procedure, the relevant associated risks and hazards involved, and any other treatment or non-treatment alternatives—along with the attendant risks of those alternatives. Thus, valid informed consent is the patient granting permission for the doctor to proceed with the recommended treatment in the knowledge of the possible consequences.
What you should understand about a stem cell procedure using bone marrow before signing an informed consent:
I understand that the following procedure is planned for me: bone marrow aspiration and injection of the concentrated stem cells (BMAC) into my painful or damaged joint. I understand that I am being asked to voluntarily consent and to voluntarily authorize the procedure(s) described below. I am being informed that the proposed procedure(s) consists of two elements or phases. The first phase involves the harvesting of my stem cells, and the second phase involves the injection of my stem cells into my painful or damaged joint. The proposed procedure will be described in further detail below.
I. Primary proposed procedure: bone marrow aspiration (Phase1)
As the patient, you should understand that the primary proposed procedure is to remove autologous bone marrow containing mesenchymal stem cells (MSCs) from the back of the iliac crest (hip area) using sterile technique. You will be positioned on a cushioned radio-lucent table in the prone (facedown) position or the lateral (side-up) position for the procedure. Your surgeon will use a state-of-the-art fluoroscopy C-arm to image your pelvic bone. This is done to make certain the bone marrow is extracted safely from the proper spot. The C-arm will be used throughout the procedure to guide the surgeon in real-time. Once properly positioned, the surgical site will be sterilely prepped-and-draped. After anesthetizing the area with local anesthetic, your surgeon will make a small incision, then insert an aspiration device that resembles a hollow needle into the bone marrow cavity (this will be done under fluoroscopic guidance). Using a syringe, your surgeon will withdraw a sample of the liquid portion of the bone marrow. You may feel a brief sharp pain or stinging. The aspiration takes only a few minutes. Several samples may be taken from different areas to increase the number of stem cells. Once the sample is taken, your surgeon will apply pressure over the site until any bleeding stops. Small strips of specialized surgery tape will be placed over the incision to bring the skin edges together. In some instances, your surgeon may elect to suture the incision. Once the incision is closed, sterile dressings will be applied. The bone marrow aspirate will be taken to our on-site processing center for centrifugation. You can comfortably rest during this phase of the procedure.
II. Primary proposed procedure: BMAC stem cell injection (Phase 2)
Once the stem cells have been concentrated by centrifugation, the second phase of the procedure will begin. The target area will be sterilely prepped and draped using sterile technique. Local anesthetic will be used to anesthetize the injection site. The stem cell concentrate will then be injected into the target area using ultrasonic guidance, fluoroscopic guidance, needle-scope arthroscopic guidance, or any combination of these injection guidance tools. Your surgeon may elect to inject the stem cells into several different locations depending on your diagnosis. Most of the time, this can all be done with a single injection. If more than one injection is required, the process will be repeated for each injection site. In some cases, your surgeon may advise the use of other products, such platelet-rich plasma (PRP) or growth factors from other sources, that are designed to improve your outcome. Use of these ancillary products may require separate and distinct informed consent forms to be signed.
III. Duration of procedure: including Phases 1 and 2)
Phase 1 of the procedure, where the stem cells are harvested from the bone marrow, should take about 20 minutes. This includes positioning, initial imaging, prepping and draping, anesthetizing the area, aspiration of the stem cells, applying pressure to the site to stop bleeding, cleaning and closing the incision, and applying sterile dressings. There will be an approximate 20-minute break between Phase 1 and Phase 2, as the bone marrow aspirate undergoes centrifugation. Phase 2 of the procedure, where the concentrated stem cells are injected into the target site, should take about 20 minutes, depending on the number of sites to be injected. This includes using ultrasound or C-arm to inspect target site. Prepping and draping the area. Anesthetizing the target injection sites. Injecting the stem cells. Applying sterile dressings and elastic bandages (in some cases).
IV. Near and long-term goals of procedure
The near-term goals of the procedure are to allow the stem cells the opportunity to begin the process of renewal and regeneration. Your surgeon will provide you with very specific post-procedure instructions that should be followed. The long-term goals are to decrease pain and improve function. This, however, is not a guarantee or warranty that the procedure will serve its intended purpose.
V. Investigational procedure acknowledgment:
This medical procedure is still considered experimental and investigative. This means it has not yet met the standard of care in the medical community. While your surgeon believes that this procedure holds promise, there are no large research studies that have shown it to be conclusively effective. The American Academy of Orthopedic Surgeons issued a position statement on the “Use of Emerging Biologic Therapies” in December 2017 that states:
“The increasing shift to therapeutic biologic products for restoring structure and function presents new questions of safety and effectiveness. No longer reserved for treating trauma and soft tissue injuries, biologic therapies are now explored as options for osteoarthritis. As we note in the statement ‘Innovation and New Technologies in Orthopedic Surgery.’ surgeons must be aware of the scientific basis for different treatment options offered to patients, including the benefits and risks. The varying regulatory pathways by which biologic therapies come to market require additional burden for surgeons to become familiar with, the Food and Drug Administration’s current thinking with respect to the source, retrieval and/or manufacturing methods, processing, storage, and use of these products, whether alone or as part of combination products. Emerging biologic therapies may lack the demonstrated safety and effectiveness profiles of many traditional orthopedic treatments. Patient education is needed for informed consent…”