Post-Operative Bracing Solutions (University of Rochester)

DonDoff Solutions Team from left to right: Swapna Kumar, Jacy Bulaon, and Frances Bell

ABSTRACT:

Surgeons may prescribe back braces to post-surgical patients to stabilize their spine. However, patient compliance and function of these braces may be affected by difficulties patients have in properly donning and doffing the back braces [1]. Patients are prohibited to bend or twist their back in order to ensure proper healing. They may also experience muscle atrophy, and have limited strength and dexterity. Our team is modifying existing spinal orthoses and the methods of donning and doffing these orthoses in order to allow patients and caregivers to easily and safely align and secure the brace. We propose three devices: a wedge-pillow, a low friction cloth, and a seat attachment, which will assist patients in donning and doffing these braces sitting or lying down. In addition, we have redesigned attachments for current braces to improve the ease in fastening and tightening the orthosis.

DonDoff Soutions Products

BACKGROUND:

About 4.6 million Americans will need back surgery at some point in their lives [2], and following surgeries such as laminectomies or spinal fusions, the orthopedic surgeon may prescribe a spinal orthosis to facilitate healing.  For post-surgical use, braces can be either custom-molded or custom prefabricated (off-the-shelf) rigid braces.  An orthotist will need to take measurements of the patient in order to supply the patient with a proper fitting orthosis which will provide support and immobilization necessary for recovery.

The goal of DonDoff Solutions is to implement products that make donning and doffing easier and safer. The patient may wear the brace between 4-6 weeks and can only take the brace off when getting into bed. This not only impacts the patient but also the physicians, nurses, physical therapists, orthotists, family members, or other caregivers.

The two methods of donning and doffing a brace that our devices assist with are the Rolling and Sitting Methods. The method used by the patient depends on physical condition, and the type and severity of surgery performed. During recovery, some patients are not allowed to sit up without the brace on, while others are able to move to the edge of the bed before donning the brace.  Those who cannot sit up require the aid of a caregiver to roll them in bed and secure the orthosis (Rolling Method).  Those who can sit up don’t require this amount of assistance, but may have difficulty managing both parts of the bi-valve brace simultaneously (Sitting Method). Through discussion with surgeons, therapists, and patients we have found that many have difficulty in aligning and securing the brace safely and easily with each method. This problem is contributes to the need for assistance from more caregivers if the patient has limited dexterity or cognitive ability. We believe that these complications in donning and doffing can lead to decreased patient compliance; the patient may choose to discontinue wearing the brace [1].  Furthermore, the nurses and/or aides cannot easily determine how to use apparently complicated braces and therefore will not be able to adequately help the patients.

In the United States, there are no existing assistive devices to help a patient take on and off spinal orthoses. Our design team is working to alleviate these concerns through creating products for both Sitting and Rolling method to help the patient and caregiver don and doff the brace in an easier manner.  For the Sitting Method, we designed a new alignment-chair with a brace holder, to support the brace during the process. For the Rolling Method, we are introducing a low-friction sheet to help slide the brace underneath the weight of the patient and a wedge pillow to help support the patients on their side. In addition, we designed a brace attachment with an innovative fastening/tightening mechanism to be used with an existing bi-valve brace.

DESIGN OBJECTIVE:

Our overall goal is to make spinal orthoses easier to don and doff.  To accomplish this we are addressing the rolling method, sitting method, and how the brace is fastened and tightened. For each of these aspects, we have specific needs and wants.

Desired features of each aspect of the design

The rolling method can be strenuous for the caregiver and discomforting for the patient due to the way that the brace is slid beneath the patient. We hope to reduce the number of caregivers required, reduce the effort it takes for them to properly align the brace, and make the process more comfortable for the patient.

The sitting method is intended for the patient to independently don and doff the brace, and thus our goal is to create a device makes it easier for the patient to do so without straining their back, juggling both portions of the brace, and decreasing discomfort in the hip joint.

Regardless of the method, a common design flaw of many existing braces is in the fastening and tightening mechanism, which involves use of multiple Velcro straps. These straps can get tangled easily and require much effort to unfasten. Changes in the patients’ size due to food in-take or side effects from medication and potential limitations in manual dexterity require a design that’s easier and faster to use.

Custom Prefabricated Orthosis

METHODS/APPROACH:

Rolling Method:

Our devices are intended to alleviate problems with the existing rolling method protocol so that the patient and caregiver generally do the same motions. The following videos are provided for comparison.

The existing Rolling Method Protocol:

DonDoff Solutions proposed Rolling Method Protocol:

Low-Friction Sheet

Our sheet is a nylon blend fabric that can be washed to maintain hygienic conditions.  Dimensions of it were chosen to span the patient’s back and sides as well as span the length of the torso. The dimensions are greater than these minimum requirements to ensure that the low friction interface can be provided between the brace and patient.

Wedge Pillow

The wedge pillow has to support the patients’ torso, which we took into account when choosing the indentation load deformation (ILD) and density of the foam. We used anthropometric data to determine the dimensions that would span the torso from shoulder to hip for most patients. In addition, we chose a 45-degree angle to increase the caregiver’s view of the patients back.

Sitting Method:

The protocol for the sitting method begins with the patient sitting up in bed. Then they sit-pivot or slide to the edge of the bed.  Our device will be level with the height of the bed, and adjustable for variable bed heights, so the patient can slide smoothly into the seat.  The seat consists of a back tilted at an angle that can be adjusted to the comfort level of the patient. When sitting up in chairs with a straight back, the brace digs into the patient’s hips. After discussing this with an orthopedic surgeon at Strong Memorial Hospital we found that this discomfort can contribute to bursitis [3]. We believe that the discomfort could then lead to disuse (less patient compliance) or improper use of the brace.  Our angle will also allow the patient to have a clear view of the front brace, increased range of motion, and will prevent the brace from digging into the hips. The back of the seat has brackets that will hold the posterior part of the brace in place at the waist groove.  After the patient slides into the chair, they can lean into the back part of the brace, and secure the front part of the brace so it is easier for the patient to independently handle two parts of the brace. They do not need to worry about holding onto the posterior portion while attempting to fasten the anterior portion.

Putting on the brace while sitting: notice bending and twisting necessary to get brace on

Putting brace on with chair

Purpose of each device in rolling and sitting method

Brace Attachment:

Our design includes two buckles on the brace used to fasten the front portion to the back.  These are double sided buckles, so the straps can insert on either side of the buckle, allowing one side of the brace to remain fastened if that makes the brace easier for the patient to manage.

Two Sided Buckle on front of Brace

To tighten the brace, there are lacing mechanisms attached to either side of the posterior portion.  For patients with limited dexterity to be able to use the device, simple loops control the lacing mechanisms and can be fixed onto the front portion of the brace with Velcro. The use of laces increases the ease of loosening the brace as the patient’s body shape may change throughout the day due to medications or constipation [3].

Brace Attachment Components


DISCUSSION:

DonDoff Solutions has designed multiple components to make the process of donning and doffing spinal orthoses easier, faster, and safer.  Through the use of the Rolling Method, Sitting Method, and the brace attachment, the patients and caregivers are able to don and doff the brace more quickly and with less effort than before. For the rolling method we decrease the effort needed by the caregiver to help the patient and increase the comfort for the patient. For the sitting method, we increase the independence of the patient by creating an easier way for them to don and doff the brace by the bedside.  Finally with our brace attachment, we are increasing the independence of the patient by decreasing the amount of effort and time required to don and doff the brace. Our devices also address patient compliance. Many times if the prescribed brace is difficult to use, the patient will forgo usage of the device, and this can delay recovery, lead to reinjury, or cause other medical complications [4,5].

FUTURE IMPROVEMENTS/EFFORTS:

We are in the final stages of prototyping each element of our design.  We plan to test the device within the next few weeks by using volunteer subjects. For the Sitting Method, we will videotape the subjects donning and doffing the brace with and without the use of our chair to test if the chair enhances the process, and conduct a detailed questionnaire to evaluate our product. For the Rolling Method we will have someone experienced with the method put the brace on the patient using the existing method of rolling and then use our Rolling Method, and conduct a survey to see if the wedge pillow and rolling sheet alleviate the problems with the existing method. To test fastening and tightening we will have the subjects use both the existing orthosis and our modified orthosis while being videotaped in order to compare the ease of using each device, time required, and number of times subjects tend to perform harmful movements of twisting and bending. We will use qualitative surveys to determine if our device is easier, faster, or more effective than the existing device.  Ultimately, we would like to get feedback from actual spinal surgery patients to determine if they find our device an improvement from existing methods. Also we would like feedback to address any need for improvement.

Since our designs focused on post-surgery patients using custom bivalve thoraco-lumbar-sacral orthoses (TLSOs), addressing other types of braces can expand the patients affected by our devices. In the future we would like to adapt our designs to be used with braces such as those used for back pain or spinal deformities.

REFERENCES:

[1] Agabegi, Steven S., Asghar, Ferhan A., Herkowitz, Harry N. “Spinal Orthoses.” Journal of  American Academy of Orthopedic Surgery; 2010(18): 657-667.

[2] American Association of Neurological Surgeons (AANS). “Study Assesses Outcomes in Spinal Surgeries Performed in 2002.” Newswise, Inc: April 2005.

[3] Dr. Paul Rubery. Orthopedic Surgeon at University of Rochester Medical Center.

[4] Fager CA. “Malpractice issues in neurological surgery.” Surgical Neurology, 2006 April; 65(4): 416-21.

[5] Miller, Laura. “5 Studies at the Forefront of Spine Surgery.” Becker’s Orthopedic, Spine, and Pain Management Review; 8 Feb 2011. <www.beckersorthopedicandspine.com/spine/3109-5-studies-at-the-forefront-of-spine-surgery>. Web. 30 Mar 2011.

ACKNOWLEDGEMENTS:

Dr. Amy Lerner (Associate Professor. University of Rochester)
Dr. Scott Seidman (Associate Professor, University of Rochester)
Dr. Joanne Wu (Physician, Spine Center at Unity Health)
Shawn Biehler (CPO, Rochester Orthopedics)
Art Salo (Laboratory Engineer, University of Rochester)
Sarah Fishel (PT, Unity Health)
Dr. Paul Rubery (Orthopedic Surgeon, URMC)
Nick Berry (Teaching Assistant, University of Rochester)

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