THE RIGIFLEX® POSTOPERATIVE SHOE:
A REVOLUTIONARY NEW SHOE FOR USE IN POSTOPERATIVE
FOREFOOT SURGERY

David John Pochatko, M.D.

ABSTRACT
Postoperative shoes are commonly used after forefoot surgery. This paper evaluates the newly patented RIGIFLEX® postoperative shoe.  This shoe provides for change in flexibility of the postoperative shoe during the postoperative period without the need to buy another shoe.    
A survey research design to assess the comfort, durability, value, and overall effectiveness of the RIGIFLEX® postoperative shoe was performed.    It was hypothesized that patients who used the RIGIFLEX® shoe would have high levels of satisfaction.  It was also hypothesized that patients who used a previous postoperative shoe would have significantly higher levels of satisfaction with the use of the RIGIFLEX® postoperative shoe.   162 patients were sent the survey.  85 surveys were completed and returned.  In response to questions regarding comfort, ease of use, and durability, the positive responses ranged from 92% to 99%.  In regards to the assistance of the shoe helping them through the healing process 88% of the patients felt it did.  88% of the respondents appreciated the ability to change flexibility of the shoe during the recovery process.

Of the 85 patients that responded, 27 had previous experience with using a postoperative shoe. Those patients that used a previous postoperative shoe felt that the RIGIFLEX® shoe was more comfortable, durable and a better value than their previous postoperative shoe, 78%, 67% and 70% of the time, respectively.  74% of the patients felt that the RIGIFLEX® shoe better assisted them through the healing process.
It was our opinion that he results of the survey support both hypotheses.
Key Words: RIGIFLEX®; Postoperative Shoe; Forefoot Surgery;
INTRODUCTION
Forefoot surgeries, including bunionectomies, metatarsophalangeal joint exostectomies, hammertoe operations, claw and mallet toe corrections, and neuroma excisions, are commonly done everyday throughout the world by general orthopedic surgeons, foot and ankle orthopedic surgeons, and podiatrists. In fact, hallux valgus surgery is the most common orthopedic operation in Western industrialized countries (Torkki et al, 2001). Postoperative shoes are commonly used throughout the recovery period from forefoot surgery to both assist in the healing process and protect the surgical site from damage.
Until recently, physicians lacked the capability to adapt the flexibility of just one shoe to accommodate all the various stages of healing. Customarily, the sole of a postoperative shoe is fixed in either a rigid, semi-rigid, or flexible state. For example, a Darco postoperative shoe (Darco International, Inc, Huntington, West Virginia) has a partial steel shank in the forefoot incorporated into its polyurethane midsole (Fuller et. al., 2001) which keeps it in a fixed rigid state. This system requires the patient to purchase a new postoperative shoe each time the demand for flexibility changes. Options for the patient are limited and ultimately costly as they progress from a rigid sole postoperative shoe to a flexible shoe. Patients, however, are often reluctant to purchase more than one postoperative shoe which may prematurely cause them to wear inappropriate footwear which may damage the surgical repair.
Dr. Pochatko’s RIGIFLEX® Postoperative Shoe(Fig.1), Sroufe Healthcare Products, provides the change in flexibility in the shoe wear that the doctor desires with the soundness of mind that the shoe will fit like he/she wants.  The shoe fits the swollen foot and can be adjusted to not place undo pressure on the surgical repair.  This study looks at the results of a survey given to patients who have had forefoot surgery and used the RIGIFLEX® shoe.
            This appears to us to be the first scientific paper to look at the use of a postoperative shoe after forefoot surgery and determine a patient’s opinion of the use of that shoe regarding comfort, ease of use, durability, value, and assistance in the healing process.

METHODS
A total of 162 patients that used a RIGIFLEX® postoperative shoe were questioned using a survey research design to test the hypotheses of this study. Only patients, who had their forefoot surgery performed between April 1st 2003 and January 31st 2004, by the senior author, were included in this study. Each patient used the RIGIFLEX® shoe ranging from one to three months postoperatively.
The survey (Fig.2) was created by a collaborative effort between Sroufe Healthcare Products’ President, Sales Manager, an independent pedorthic facility, and the senior author. The survey included questions on different aspects of the RIGIFLEX® shoe, including each patient’s opinion regarding its comfort, ease of use, durability, and overall assistance throughout the healing process. For those patients who had previous experience with a rigid postoperative shoe, additional questions were included comparing that shoe use with the RIGIFLEX® postoperative shoe. The survey was limited to one page and included a self-addressed stamped envelope in order to ensure the maximum return rate. Only fully completed surveys were used in the data collected and returning the completed surveys implied consent to be a study participant.

RESULTS
Surveys were mailed to 162 patients who used a postoperative shoe following forefoot surgery performed by the senior author between April 1st 2003 and January 31st 2004. Of the 162 surveys sent, 92 surveys were returned yielding a response rate of 57%. Seven surveys were found to be incomplete and were discarded. Therefore, the useable sample consisted of 85 surveys. Table 1A shows descriptive statistics on the demographic characteristics of the sample. Of the 85 patients included in the study, 84.7% were women and 15.3% were men. Table 2A indicates the means, modes, and age ranges of the sample surveyed. The mean age of the sample was 41 years old, with a mode of 46, and ages ranging from 21 to 85 years-old.
 Answers to the questions regarding comfort, ease of use, and durability were favorable in 92%, 99%, and 96% of respondents respectively. When concluding if the
Fig. 1: RIGIFLEX® shoe demonstrating its two removable plastic shanks with Velcro (Velcro USA, Inc, Manchester, New Hampshire) straps which allows the shoe to transform from a rigid, semi-rigid, or fully flexible position.

Fig 2: Survey
DR. POCHATKO’S RIGIFLEX® POSTOPERATIVE SHOE SURVEY

This survey is being done, so that those who have used the RIGIFLEX® shoe can give us their opinion regarding the shoe.  With this information we will be better able to provide for our patients.  Thank you

What was the reason for wearing the shoe?        ____________________________________
How long did you wear the shoe(weeks/months)?           ______________________________

If you wore a postoperative shoe before, please
answer the following questions, otherwise, you’re
done. Skip to the bottom

Do you have any comments       ____________________________________________________
to make the shoe better?           

Thank you for completing the survey.  Please mail survey back to us in self-addressed, stamped, envelope.

shoe assisted the patient in the healing process, 88% of patients agreed or strongly agreed. In regard to its ease of use and overall value, the positive responses were 92% and 86% respectively. When asked about the convenience of changing the flexibility of the
RIGIFLEX® shoe versus trying to find another shoe that would fit their swollen foot, 88% of respondents agreed or strongly agreed that it was a good feature. Ninety-two percent of the respondents stated that they would use the RIGIFLEX® shoe again or recommend it to a friend.
Twenty-seven patients had previous postoperative shoe experience.  This represented 32% of the qualified surveys.  Demographics are listed in Table1B and Table 2B.  When comparing the RIGIFLEX® shoe with previous postoperative shoes, the results showed that the RIGIFLEX® was the better shoe throughout all areas surveyed. In regard to comfort, durability, and value the respondents agreed or strongly agreed that the RIGIFLEX® shoe was the better shoe 78%, 67%, and 70% respectively. When comparing the patients’ belief that the RIGIFLEX® shoe better assisted them in the healing process postoperatively then their previous postoperative shoe, 74% agreed or strongly agreed that the RIGIFLEX® shoe was better.
The results of the survey support both our hypotheses that the RIGIFLEX® shoe gave patients high levels of satisfaction with the use of the shoe as well as higher levels of satisfaction when compared to previous postoperative shoe use.
Outlier analysis was performed using standard deviations.  The analysis improved the results of 7 of the first 8 questions from 1.1% to 4.5%, average 2.0%.  The four questions regarding prior use of a postoperative shoe showed a positive outlier change in only one of the four questions.  The other questions had no change.
Comments regarding improving the shoe were too few and variable to be significant enough to report.  One thing that we see with the use of the shoe that we are addressing is the Velcro that holds the shanks in place needs to be upgraded.   When the patient is ambulating with the shoe this area may loosen allowing the shanks to protrude a little from the heel of the shoe.  Another observation that the surgeon needs to note is that the heel counter, that assists in preventing heel slippage when ambulating, needs to be padded when applying the initial dressing to help prevent blistering of the skin over the Achilles’ tendon caused by pressure from elevating the foot and resting the shoe/foot on something.  This didn’t happen often, but since applying an ABD pad over the Achilles’ area with the initial bandage we have not seen this problem again.

DISCUSSION
. In its most rigid position, a postoperative shoe is sufficient to protect most stable, undisplaced fractures (Downey, 1992). They also protect forefoot procedures ranging from Akin, distal Chevron, and proximal metatarsal osteotomies (Clark, 1991; Gerbert, 1991). After forefoot surgery, it is common for surgeons to prescribe a postoperative shoe to accommodate the bulky dressing and swelling of the foot, and to protect the surgical correction from damage. Prior to the newly-patented, adjustable, RIGIFLEX® postoperative shoe, options following surgery were limited to a shoe either in a fixed rigid, semi-rigid, or flexible position. During the postoperative period, however, it would not be uncommon for the patient to progress from one state of flexibility to another. For example, a patient may begin the postoperative period in a rigid shoe, such as following a cheilectomy of the first metatarsophalangeal joint for arthritis, but progress quickly to weight-bearing-as-tolerated in a flexible soled shoe all perhaps within the timeframe of one week. Traditionally, changing the flexibility of the shoe required the patient to purchase either another postoperative shoe, purchase a normal shoe that was larger than what the patient would ordinarily wear to accommodate the swollen foot, or inappropriately try to squeeze their foot into a shoe they already own. Often, a patient is reluctant to purchase a second postoperative shoe. In the current malpractice environment, it is prudent that the surgeon follow-up with the patient regularly to ensure he or she is compliant with after-care recommendations. This includes careful monitoring of shoe wear in the acute postoperative period.  The RIGIFLEX® shoe solves this problem by allowing the surgeon to change the flexibility of the shoe worn in the postoperative period while knowing the fit of the shoe will not damage the surgical repair.
The results of the survey clearly demonstrate that the RIGIFLEX® shoe is a comfortable, durable shoe that is easy to use and walk in, and provides the protection patients need all throughout the postoperative recovery. Patients believe this shoe is an excellent value do to its versatility and adjustability.
When operating on a patient, a doctor will always prefer the equipment that will give the patient the best results.  The RIGIFLEX® shoe survey demonstrates that not only do most patients believe that the shoe better assisted  them in their healing process, but 74% felt the RIGIFLEX® shoe assisted them in their healing process better than their previous postoperative shoe.

Table 1A

Demographic Variable              Frequency                    Percent

Females                                                72                                            84.7

Table 1B

Demographic Variable              Frequency                                Percent

Females                                                22                                            81.5

Table 2A

                                                                        Patients Surveyed (n = 85)

Table 2B

Patients Surveyed (n = 27)

Limitations of the study exist in that no previous studies on other postoperative shoes were available for comparison. Also, although postoperative shoes are used for the treatment of many various procedures and fractures types, they are also used for non-surgical treatment of such disorders as planter fasciitis, metatarsophalangeal injuries in athletes, rheumatoid arthritis, trauma, and neuropathic ulceration. To best control for these difference among the normative population only forefoot surgeries were included in this study. When comparing the RIGIFLEX® shoe to previous postoperative shoes we did not find out which shoe was worn before.  We also did not take into account the success of the surgical procedure and the influence it may have had on the survey results.  Finally, a modified version of the Dillman (1978) method could have been used for the implementation of the mailed surveys to further maximize the return rate. The Dillman method describes a minimum of three follow-up mailings to be sent within 7 weeks after the original survey.

CONCLUSION
The RIGIFLEX® postoperative shoe is a revolutionary new shoe that provides better control over a patient’s footwear during the postoperative period after forefoot surgery. The surgeon can have confidence that the shoe their patient is wearing is of the appropriate flexibility and will fit properly to maximize success of the operation and reduce the chance of complications
The results of the survey clearly demonstrate that the RIGIFLEX® shoe is a comfortable, durable shoe that is easy to use and walk in, and provides the protection patients need all throughout the postoperative recovery period. Patients believe this shoe is an excellent value due to its versatility and adjustability. Not only did most patients believe the RIGIFLEX® shoe successfully assisted them in their healing process, but 74% felt the RIGIFLEX® shoe assisted them better than their previous, rigid postoperative shoe.

AUTHOR’S DISCLOSURE STATEMENT
Dr. Pochatko currently receives a royalty from Sroufe Healthcare Products on the sale of the RIGIFLEX® shoe.
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REFERENCES
1.  Dillman, DA: Mail and telephone surveys: The total design method. New York:
Wiley, 1978.
2.  Fleischli, JG; Lavery, LA; Vela, SA; et al: Comparison of strategies for reducing
pressure at the site of neuropathic ulcers. JAPMA 87: 466, 1997.
3.  Fuller, E; Schroeder, S; Edwards, J: Reduction of peak pressure on the forefoot
with a rigid rocker-bottom postoperative shoe. Foot Ankle 91(10): 501-507, 2001.
4.  Mann, RA; Coughlin, MJ: Adult hallux valgus. In: R Hurley, ed, Surgery of the Foot
and Ankle, St. Louis, Mosby, 1999, p. 150-269.
5.  Torkki, M; Malmivaara, A; Seitsalo, S; Hoikka, V; Laippala, P; Paavolainen, P:
Surgery vs orthosis vs watchful waiting for hallux valgus. JAMA 285(19): 2474-2480, 2001