A prosthesis as defined by the Centers for Medicare and Medicaid services as “…devices that replace all or part of an internal body organ or replace all or part of the function of a permanently inoperative or malfunctioning internal body organ.”
Prosthetics include limbs, eyes, teeth, and facial bones. It is important to note that Magnolia Medical Orthotics & Prosthetics only does prostheses for limbs.
There are two types of prostheses, endoskeletal and exoskeletal. Endoskeletal means that the prosthesis is supported by an internal pylon. Exoskeletal means the prosthesis is supported by an external frame.
Your Prosthetist is the person in charge of your prosthetic care.
Magnolia Medical Orthotics & Prosthetics’ Prosthetists are experienced and have the skills and knowledge necessary to provide the best prosthesis for you.
After your amputation, a referral will be made to a prosthetics facility. When we receive a referral from a physician, we see the patient while they are still in the hospital if at all possible. First the Prosthetist will introduce him or herself and explain the prosthetic process to you.
Typically, you are fit with a “shrinker” at this time. A “shrinker” is used for compression to control swelling and promote healing. It will also help shape the limb to prepare it for a prosthesis. There is a period of healing that can last for a varied amount of time depending on the patient. Once healing is complete, your Prosthetist will continue the prosthetic process.
Typically, after your surgery the Prosthetist will see you in the hospital before you are discharged. This is because the physician makes the referral to the Prosthetist while you are in the hospital. This is when they will go over the Prosthetic process with you, give you brochures, and provide you with all information necessary. Your Prosthetist will leave you with a business card for you to hold on to. The business card will have your Prosthetist’s name on it with contact information.
Magnolia Medical Orthotics & Prosthetics will obtain your contact information from the hospital so we can continue the prosthetic process when you are discharged home or to another facility.
We understand that there is a lot of information to keep track of when you have an amputation. Magnolia Medical Orthotics & Prosthetics will be in contact with you to help guide you smoothly through the prosthetic process. You are always encouraged to call us with any questions you may have.
There is no set time frame for obtaining a prosthesis. The time frame for obtaining a prosthesis varies from patient to patient, and usually depends on healing time. If a patient has vascular deficiencies, they may not heal as quickly and this can make the process longer.
Once the patient is sufficiently healed the Prosthetist will proceed with the initial evaluation, scan, and measurements. Sometimes instead of a scan, a cast is taken to obtain a plaster mold of the patient’s limb.
Once this is completed the Prosthetist will proceed with the first test socket fitting. This is to test how well the socket fits from the scan or mold taken from the patient. If the test socket fits well and does not need any significant changes then the Prosthetist will proceed on to a definitive prosthesis if appropriate.
Some patients may need a temporary prosthesis first. Your Prosthetist will discuss the options with you to see what is best for you and your situation.
Most of the time when a patient receives their first prosthesis, it is not always comfortable. There is an adjustment period where the patient will need to get used to wearing a prosthesis. You should always call your Prosthetist if something is irritating your skin or causing you pain.
It is not uncommon for a prosthesis to rub in certain areas. This can be corrected by your Prosthetist to make the prosthesis more comfortable. If there is ever a time you are unable to wear your prosthesis because the socket is too large or too small, call your Prosthetist immediately. It is very important to take care of these issues as soon as possible. Various factors can cause your limb to swell, making your prosthesis tight. Also, wearing your prosthesis throughout the day can cause your limb to decrease in size. Your Prosthetist will go over these issues with you.
Magnolia Medical Orthotics & Prosthetics strongly encourages you to schedule an appointment before coming in.
Always try to call ahead of time before coming in if you are able to. This will ensure the Prosthetist is available to see you in a timely manner.
Please call and ask if we accept your insurance. Magnolia Medical Orthotics & Prosthetics works with most insurance companies, but it’s always best to call and ask before coming in.
We like to follow up with prosthetic patients every couple of months. We check the prosthesis for wear and tear, check condition of supplies such as socks and liners, and see how you are functioning with the prosthesis. Please feel free to call us if you are having any issues including but not limited to tears in your liner, or pain wearing your prosthesis. A simple adjustment might be all that is needed to keep you comfortable.
No. Even though the components are made of durable materials, they are not meant to last forever. Eventually parts and materials break down. You may need several prostheses over your lifetime.
Call Magnolia Medical Orthotics & Prosthetics immediately! It is extremely important we know about any damaged parts as soon as possible. Even if it is after hours, you can leave a message with our answering service and the on-call Prosthetist will receive the message, so we can schedule you an appointment. The Prosthetist will take care of your situation to keep you comfortable and safe.
According to the Centers for Medicare and Medicaid services, “A brace includes rigid and semi-rigid devices that are used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.”
An orthosis can be pre-fabricated or custom fabricated. Pre-fabricated orthotics are those that are ready to wear and may need minor modifications for comfort, and come in various sizes. For example, the Aspen and Donjoy LSOs are pre-fabricated and come in a variety of sizes.
Custom fabricated orthotics are created from a mold, impression, or measurements of an affected area on the patient. The process of receiving some type of orthotics may take longer because they must be fabricated.
The type of orthosis you are receiving usually dictates the time frame for delivery. If you are receiving a pre-fabricated orthosis and we have the size in stock for you, then you may receive the orthosis that day. If you were prescribed a custom orthosis, your first visit will consist of taking an impression, taking a scan, and/or measurements. These will be used to fabricate an orthosis that you will come back for at a later date. Sometimes a week or 2 is necessary for fabrication, but this time frame varies.
Orthotics are designed to correct musculoskeletal deformities and may not always be comfortable to wear. Sometimes adjustments are needed for comfort. Your Orthotist will evaluate your orthosis and how it is affecting your comfort, and make adjustments as necessary. The Orthotist will also explain the wear schedule for orthotics. The wear schedule is designed so that you can “break in” the orthosis and give your body a chance to become accustomed to it. Always call your Orthotist if you are experiencing redness on your skin for longer than 15 minutes after taking off the orthosis, if you have developed blisters from wearing the orthosis, or if the orthosis is causing you pain.
The type of material your orthosis is made of will determine how to clean it. If your orthosis contains a lot of Velcro material, you will most likely be advised to use mild soapy water on a sponge, wipe it down and let it air dry. Do not submerge Velcro underwater.
If your orthosis is made of a plastic material, you will most likely be able to use mild soapy water on a sponge to wipe it down, rinse it, and let it air dry. Your Orthotist will give you instructions on how to maintain your orthosis.
The wear schedule for an orthosis depends largely on the condition being treated and physician’s instructions. Your Orthotist and Physician will go over this with you. For example, if a patient is wearing a Aspen cervical collar that was prescribed after a cervical fusion procedure, they may have to wear the cervical collar for approximately 6 weeks until the physician tells them they do not have to wear it anymore. Usually you stop wearing an orthosis after a condition has resolved, and this is always determined by your physician.
Bone Growth Stimulator FAQ
Wearing and Operating Your Stimulator:
Yes, it can be worn over an orthopedic brace or clothing without affecting the PEMF signal as it will still reach the fusion site.
You won't feel the PEMF therapy, and the device is lightweight and adjustable for a comfortable fit. It is powered with a rechargeable battery, which allows the unit to be portable. You can sit, stand, sleep, walk, recline, and drive while using your device. With your physician's approval, you can resume a normal activity level.
Treatment is based on a daily therapy schedule. Your doctor will prescribe the device for a certain number of hours each day, based on your needs. The minimum daily treatment time is two hours per day for the SpinalStim™ device, three hours per day with a PhysioStim™ device, and four hours per day with the CervicalStim™ device.
Yes. You can split up treatment sessions. It is recommended that the treatment sessions be a minimum of 60 minutes. Patients have the flexibility to receive treatment at any time during the day. The device has a built-in 24 hour clock which allows treatment each day between the hours of 12:00 a.m. through 11:59 a.m. (Central Time, unless adjusted for your time zone).
No. You have the flexibility to receive your treatment at any time during the day. The device has a built-in 24 hour clock which resets daily at 12:00 midnight, Central Time, unless adjusted for your time zone. Additionally, you may choose to break your total daily prescribed treatment into a number of shorter sessions lasting at least one hour each, in accordance with your doctor's instructions.
The healing process itself determines the duration of the treatment, and your physician will closely monitor your progress. Your individual risk factors (such as smoking, multi-level fusion, and graft type) and your compliance in wearing the device will factor into the duration of your treatment. To promote your healing, it is very important that you wear the bone growth therapy device daily as prescribed. Your doctor may require that you bring your unit in on your follow-up visits to check your compliance. Most patients wear the device between three and nine months.
Humans can't sense a PEMF waveform, so you'll never feel a treatment. If your device display shows a timer countdown, the unit should be working. If at any time the device stops showing a treatment timer or shows a code starting with the letter E, please contact Magnolia Medical at (225) 615-8693
One year. If at any time you need a replacement charger or foam insert cushion, please contact Magnolia Medical at (225) 615-8693.
Orthofix Bone Growth Therapy devices are devices that should only be used by the person for whom it is prescribed. The device is yours to keep once your treatment is complete.
While the battery for Orthofix Bone Growth Therapy devices will last for an average of ten treatment hours, it is strongly recommended that the device be recharged after completing daily treatment. The device will not deliver treatment while charging.
Please check that the power supply is plugged all the way into the AC Wall Outlet. If the power supply is fully connected, the blue LED will be lit on the barrel connector. If the power supply and the device are connected properly, the unit displays a battery icon with scrolling bars.
SpinalStim™, CervicalStim™ and PhysioStim™ devices can be cleaned by wiping surfaces with a damp, soft cloth (wet with water only). Do not use solvents or expose to excessive moisture.
Cleaning foam inserts or cushions:
- Hand wash in cold water using a mild laundry detergent (do not dry clean or clean with bleach or other solvents).
- Wring out excess water and pat dry with a clean towel.
- Lay flat until completely dry (do not put in the dryer and do not iron).
The unit has expired. Please consult with your physician.
When traveling by air, it is recommended to pack stimulators with checked luggage. If taken onboard the airplane, it should be turned off when passing through security screening equipment, as the device could be damaged. The instruction manual should be taken with you to quickly and easily identify the device for security personnel.
Bone Growth Stimulator Safety:
Yes. Bone growth therapy devices produce a signal at the fusion site like the one your own body generates to induce normal bone healing. The PEMF therapy emitted by Orthofix Bone Growth Therapy devices was specially designed with your safety in mind, and is similar in strength to what you're exposed to naturally from the magnetic field of the earth. More than 800,000 patients have worn our devices to increase the probability of fusion success or to heal a non-union fracture.
Yes. SpinalStim™, CervicalStim™, and PhysioStim™ devices are FDA approved as a Class III medical devices. The PhysioStim device was approved by the FDA in 1986, the SpinalStim device was approved by the FDA in 1990, and the CervicalStim device was approved by the FDA in 2004.
The PhysioStim™ device is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Use of this device is contraindicated where the individual has synovial pseudarthrosis.
- The safety and effectiveness of the use of this device on individuals lacking skeletal maturity has not been established.
- In the presence of a malaligned nonunion, careful consideration of the use of this device must be undertaken on an individual basis, as treatment with this device is not intended to alter or affect the degree of malalignment.
- Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. Physicians should not prescribe a PhysioStim for application which may place the treatment transducer in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram).
- Animal studies conducted to date do not suggest any long-term adverse effects from the use of this device. However, long-term effects in humans are unknown.
- The safety and effectiveness of this device on individuals with a nonunion secondary to, or in connection with, a pathological condition has not been established.
- Nonunion fractures with gaps in excess of 1 centimeter (cm) have not been evaluated.
- Although animal reproductive studies performed with this device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
- This device should not be used if there are mental or physical conditions which preclude patient compliance with physician and device instructions.
Rare instances of reversible minor discomfort have been reported. They were: cumbersome or uncomfortable, tingling or pain and minor skin rash.
The SpinalStim™ device is a non-invasive electromagnetic bone growth stimulator indicated as a spinal fusion adjunct to increase the probability of fusion success AND as a nonoperative treatment for salvage of failed spinal fusion, minimum nine months postoperative.
Cardiac pacemakers may be adversely affected by exposure to PEMF. Use of this device is contraindicated where the individual has an implanted cardiac pacemaker.
- Although animal teratological studies performed with the device demonstrated no adverse findings, the safety of use of this device during pregnancy and nursing in humans has not been established.
- The safety and effectiveness of the use of this device on individuals lacking skeletal maturity have not been established.
- Animal studies conducted to date do not suggest any long-term adverse effects from the use of a similar device. However, long-term effects in humans are unknown.
- This device should not be used if there are mental or physical conditions which preclude compliance with the physician and device instructions.
- This device has not been evaluated in treating patients with the following conditions: osseous or ligamentous spinal trauma, spondylitis, Paget's disease, moderate to severe osteoporosis, metastatic cancer, renal disease, and uncontrolled diabetes mellitus.
- The results of premarketing data from the randomized double-masked cohort indicate that inconsistent users (defined as those patients that used the device for less than an average of two hours per day) had success rates similar to those in the placebo group. Therefore, the use of the device for less than the minimum recommended usage may result in lower success rates.
Rare instances of reversible minor discomfort have been reported. They were: cumbersome or uncomfortable, minor tingling or pain, minor skin rash, insomnia, fainting, nausea/diarrhea, and polymenorrhea.
The CervicalStim™ device is a noninvasive, pulsed electromagnetic bone growth stimulator indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
There are no known contraindications for the CervicalStim device as an adjunct to cervical spine fusion surgery.
- Do not use CervicalStim device if you have a cardiac pacemaker or defibrillator because it may interfere with the operation of your pacemaker or defibrillator. If you use the CervicalStim device and it affects your pacemaker or defibrillator, it may injure your heart. Consult your cardiologist.
- Remove the CervicalStim device prior to any imaging procedures (e.g., CT scan, MRI, etc.). If you wear the CervicalStim device during these procedures, you could be injured, the imaging being produced may be ruined, and/or the CervicalStim device could be damaged.
- Avoid using the CervicalStim device if you do not understand the instructions your doctor has given you. If you use the CervicalStim device incorrectly, it may harm you or may not help your healing process.
- The CervicalStim device has not been evaluated in treating patients with the following conditions: osseous or ligamentous spinal trauma, spondylitis, Paget’s disease, moderate to severe osteoporosis, metastatic cancer, renal disease, rheumatoid arthritis, uncontrolled diabetes mellitus, patients prone to vascular migraine headache, seizure, epilepsy, thyroid conditions or neurological diseases.
- Animal reproductive studies performed with this device did not show any harmful effects in animals. However, the safety of this device for use on patients who are pregnant or nursing has not been established.
Adverse effects may be experienced when using the CervicalStim device. These adverse effects may include: increased pain, numbness and tingling, headache, migraines and nausea. These effects may or may not be directly related to the use of the CervicalStim device. Any adverse effects that are related to the CervicalStim device should stop when you discontinue use.
The safety of use of this device during pregnancy and nursing in humans has not been established.
The effect of PEMF treatment was studied in patients with skeletal maturity and has not been studied in patients lacking skeletal maturity. Your doctor will determine when use is medically appropriate.
Using a SpinalStim™ device with an implanted cardiac pacemaker or defibrillator is contraindicated, while it's a warning with the CervicalStim™ and PhysioStim™ devices.
Demand type pacemaker operation may be adversely affected by exposure to pulsed electromagnetic fields. Physicians should not prescribe a SpinalStim, CervicalStim, or PhysioStim device for application which may place the treatment transducer in close proximity to the pacemaker. Further screening by the attending cardiologist is recommended (such as with an electrocardiogram).
It's important to consult your cardiologist, who can run tests to determine whether the device will affect your specific pacemaker model.