Stretch Beyond Your Expectations.

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Mervyn Whitehead
5 years ago
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CLINICIAN INSTRUCTIONS Dynasplint Toe Metatarsophalangeal Extension System Type III Corporate Headquarters: 800.638.6771 toll-free 800.380.3784 fax Canada: 800.668.9139 toll-free 905.851.

1 CLINICIAN INSTRUCTIONS Dynasplint Toe Metatarsophalangeal Extension System Type III Corporate Headquarters: toll-free fax Canada: toll-free fax Europe: phone fax Indication: Dynasplint Metatarsophalangeal Systems are used for the treatment and prevention of joint stiffness from immobilization or established contractures arising from: Bunionectomies, implants Hallux limitus Hammer toes/arthroplasty Fractures Dislocations Tendon and ligament repairs Capsular contractures Base wedge, lapidus procedure DYNASPLINT and Dynasplint Systems are registered trademarks of Dynasplint Systems, Inc. Stretch Beyond Your Expectations.

2 FITTING INSTRUCTIONS IMPORTANT: Movement and rattling of spacer in the tension window is normal. This will subside when more tension is applied to the tension screw. STANDARD FITTING INSTRUCTIONS: STEP 1: With patient sitting in chair or on bed, loosen the set screws on the horizontal bar, slide the unit onto the foot so that the great toe rests fully on the toe thermoplastic piece. The thermoplastic piece must be vertical for the great toe only or horizontal for two or more toes. Make sure the joint axis is aligned with the metatarsophalangeal joint. STEP 2: To shorten or lengthen the strut, first remove the 1/8 screws near the cams. Slide the smaller tube in or out of the larger tube to obtain correct length. Replace and gently tighten screws, making sure that they sit in the predrilled holes. Repeat as necessary for opposite struts. See Figure 2. The first hole should not be used due to poor viewing in the tension window. STEP 3: While maintaining a comfortable width to allow clearance for the foot from the cams, tighten the two set screws on the horizontal bar. FIGURE 1. Shoe Strut Strut Set Screw Set Screw Counterforce Strap Cam Round Rotatable Mounting Plate Alignment Horizontal Bar STEP 4: Make appropriate adjustments to the rotatable mounting plate, horizontal bar and vertical stem rod to achieve an accurate and comfortable fit. Mounting plate should fully contact bottom of toe. See Figures 1 & 2. These adjustments will be made with the enclosed wrenches. STEP 5: Close and tighten the counterforce straps. This will provide proper alignment with joint axis of the metatarsophalangeal joint. STEP 6: Take off the unit and adjust the tension to the proper setting (see Protocol). 1

3 FIGURE 2. Velcro Straps Round Rotatable Mounting Plate Vertical Stem Rod Shoe Struts Set Screws Horizontal Bar Cams Counterforce Strap Tension Scale STEP 7: Check the alignment with Figures 1 & 2, making sure that: Cams are aligned across the metatarsophalangeal axis. Struts are placed on the medial and lateral side of the foot. Shoe is evenly contoured across the foot, with enough space to slide one finger under all the straps. Make sure the great toe is resting completely on mounting plate. STEP 8: Mark the straps to prevent alteration of the fitting by the patient. STEP 9: Make a reference line with a permanent marker on the counterforce strap to assist the patient in closing the straps to the proper tightness. STEP 10: Have the patient practice applying and removing the unit. Sizing: Two types of units are available. Type I Strapping system; accommodates shoe size 13 or higher more effectively Type III Large = Shoe size 8-13 Small = Women s shoe sizes 7 or smaller Give the patient the Patient Instruction Booklet to take home with the Dynasplint Toe Metatarsophalangeal Extension System. 2

4 Non-Surgical/One Year Post-Operative Toe Patient Protocol Patients should wear the unit at the highest tolerable tension setting (max 4) for the longest time possible. Optimally, the patient will wear the Dynasplint System for four to six continuous hours. However, wearing time of two to four cumulative hours during the day, preferably in one applied session is adequate for improving range of motion. The tension should be set to produce as much as, but not more than, 30 minutes of post-wear stiffness beyond normal discomfort (15-30 mins. is ideal). Success in restoring range of motion depends on patient tolerance and compliance, length of time since onset, and cause and severity of stiffness/contracture, e.g., bunionectomy, functional hallux limitus, fracture, dislocation, ligament repair, etc. STANDARD PROTOCOL Protocols vary according to individual health practitioners discretion. 1. Conditioning and adaptation. Important: Movement and rattling of spacer does not mean the unit is broken. This will subside when more tension is applied to the tension screw. a. Day 1: Set tension screws at 1 on both struts. Have the patient wear the unit for one period of up to two continuous hours. If the patient complains of pain during the two-hour period, or reports more than 30 minutes of post-wear stiffness/ discomfort, reduce tension by 0.5 increments or more if necessary on each strut, until the patient can wear the unit four continuous hours per day. b. Advance tension setting by increments of 1.0 as tolerated to produce as much as, but not more than, 30 minutes post-wear discomfort/stiffness beyond normal discomfort. Higher tension settings are not always necessary to achieve results. 2. The patient should be inactive and relaxed while wearing the unit. The extremity should be in a gravity-eliminated position. Position the patient while sitting, with leg resting level with the heart. In no way should the extremity be dependent. It is important that some kind of support be placed underneath the heel (such as a pillow) to prevent the struts from protruding down and consequently pushing the unit forward. In other words, the alignment may be thrown causing the toe to slip off the thermoplastic piece. 3. If the patient complains of pain, numbness, or discomfort while wearing the unit, remove the unit. Reapply the unit after reevaluation by the Dynasplint Systems sales consultant if possible. 4. If the patient cannot adapt to 6-hour wear, have the patient use the Dynasplint System during the day. In most cases, incorporating Dynasplint Systems early in treatment will decrease rehabilitation time. 3

5 Protocol for Post-Operative Toe Patients The Dynasplint Toe System has proven to be very successful in the treatment of postsurgical stiffness and pain. Osteotomy procedures vary. Every physician should clear the intended patient for passive range of motion (PROM) therapy. Some examples of procedures include the McBride, the Cheilectomy, and the Silver technique. These are considered the least invasive, and have best recovery phase, therefore allowing for the earliest application of the Dynasplint System, as early as 7 to 14 days post-operatively. The hemi-implant procedure is often grouped here with an equally early application of the unit. The most common post-operative diagnosis has been 1 st MTJ Hallux Abducto-Valgus surgery. The unit can be applied as early as 14 days (2 weeks) post-operatively. This is the time that sutures are typically removed. The application of tension is applied to the plantar surface of the hallux, therefore, no direct pressure is applied to the distal metatarsal, thusly eliminating any compromise to the surgical site and any implant. In addition, the physician will make the decision considering the operative procedure and success for even earlier application where necessary. There are examples of Dynasplint applications within 2 or 3 days as a result of a strong surgical success, otherwise known as a good bite or fixation. Some examples of less stable osteotomy procedures would include the Austin, and variations of that surgical technique. These patients have the greatest success with application 2 to 3 weeks post-operatively. This additional time frame allows for greater healing to occur, and PROM to be introduced at the most critical time of recovery. The last example would be the Akin procedure. This may result in greater instability due to surgical preference, with or without the fixative procedure involved. These patients are normally prescribed a Dynasplint System between 2 and 6 weeks post-operatively. This window of availability is wide due to the variety of surgical techniques, and the use or non-use of fixation in the foot. Starting time for status post-surgical patients may vary considerably according to individual Orthopedic and Podiatric Surgeons. Diagnosis and surgical techniques are the major factors, as indicated previously, to be addressed before beginning use of a Dynasplint Toe System. Please also consider the patient s medical history, e.g., history of diabetes, unstable fractures, cancer, smoking addiction, etc. Instructions to restore functional range of motion for surgical patients: The patient s goal is three 10-minute sessions per day until the patient can complete the time frame without any post-wear stiffness. The patient has no time schedule to complete this task at an initial setting of 2 on the tension scale. The average patient may take one to three days to complete each level. Once the first level is achieved the patient will then increase to a 20-minute session three times a day until this goal has been completed without any post-wear discomfort. The patient will continue this pattern, i.e., 30 minutes three times a day until 60 minutes three times a day is achieved. 4

6 Patients may also plateau at a certain level for seven to ten days. When the patient reaches 60 minutes three times a day without any post-wear discomfort, the tension may be adjusted to a setting of 3 on the tension scale. The patient would start all over again with three 10-minute sessions a day followed by three 20-minute sessions, and so on. Patients who may have trouble increasing their wearing time or are continuing to have a lot of post-wear stiffness must lower the setting by one. Wearing time is more important than tension. Missing a session because of discomfort is not uncommon. If the patient has discomfort, increased swelling or has been on their feet excessively the splint should be removed and another wearing session attempted later in the day. The Dynasplint System is a low-load, prolonged-duration stretch and intended to be comfortable. TENSION ADJUSTMENT STEP 1: Hold the unit so that you can see the tension adjustment scales on one of the thick tubes (struts). Holding the unit vertically, with the 0 towards the ground, may be easier to view the tension scale. The etched line on the spacer inside the strut (visible in the tension window) will line up with a number on one of the scales. See Figure 3. STEP 2: If the tension is not on 0 on both struts, adjust the tension screws inside both struts, so that the etched line on the spacers lines up with 0. See Figure 3. Tension Screw FIGURE 3. SPECIFICATIONS - STANDARD Weight: ADULT oz. Range of Motion: 0 to 90 of extension SETTING ON SCALE TOE EXTENSION Measured at 35 Flexion N/A N/A Torque values expressed in foot pounds. 5

7 TROUBLESHOOTING Instruct patient to remove the Dynasplint System immediately if pain or numbness occurs. PROBLEM: SOLUTION: Pain. Decrease the tension by 0.5 increments until the unit is tolerated. Do not decrease the wearing time unless absolutely necessary. PROBLEM: SOLUTION: Numbness. Check if straps are too tight. Decrease the tension by 0.5 increments until the unit is tolerated. Repeat adaptation wearing schedule. PROBLEM: SOLUTION: Comfort pads or Velcro are irritating the skin. Use stockinette between foot and splint. CONTRAINDICATIONS: Although Dynasplint Systems can provide unusually conservative stretching force, these devices are contraindicated where range of motion therapy is inappropriate. PRECAUTIONS: Severe osteoporosis, thrombophlebitis, severe spasticity, and in any instance in which ulceration is a problem. NOTE: This device is restricted to use on the order of a licensed health care practitioner. 6

8 1996 Dynasplint Systems, Inc. Dynasplint Systems, Inc. products are covered by one or more of the following U.S.A. patents: 5,558,624; 5,645,521; 6,413,231; 6,506,172; 6,740,051; 6,908,475; 6,942,629; 6,942,631; 4,485,808; 4,508,111; 4,538,600; 4,944,290; 4,947,835; and 5,070,868. Other patents issued and/or pending in the U.S.A. and internationally. The product described in the enclosed literature is intended for the specific purpose as per the instructions attached. Any use of this product outside of its intended purpose on any body part or in a manner outside the protocol established by Dynasplint Systems, Inc., is a use of the product for which it, its divisions and employees cannot be held responsible. All implied warranties of fitness for use for any other purpose (or purposes) are expressly disclaimed.

Stretch Beyond Your Expectations.

Stretch Beyond Your Expectations. CLINICIAN INSTRUCTIONS Dynasplint Proximal Interphalangeal Joint Extension System Corporate Headquarters: 800.638.6771 toll-free 800.380.3784 fax Canada: 800.668.9139 toll-free 905.851.3494 fax Europe: