Limb loss can be a result of vascular disease, trauma, malignancy, or congenital anomalies. Loss of a limb after established functionality can be catastrophic in ones daily life. Factors such as ambulation, appearance, frustration, and pain can all be affected by the loss of a limb. The burden of loss not only affects the patient but also alters the family dynamics. Limb loss has been identified as producing the highest risk of functional disability.1 The type and quality of the prosthesis that is received after surgery may affect the patients’ perception about their life.2 The purpose of this research project was to measure the quality of life in two groups of persons with lower limb amputation after the placement of a prosthesis. The first group consisted of patients who received an early postoperative prosthesis (EPOP) with subsequent placement of a permanent prosthesis. The second consisted of those who receive a temporary and permanent prosthesis 8 weeks up to 2 years after amputation surgery. The specific aim was to measure the difference in the quality of life related to physical, psychologic, social or role functioning, and well-being related to the function of their prosthesis in the two groups. This exploratory study may be used in EPOP programs to map interventions that may be unique to this previously unstudied group of persons who receive early prostheses.
Prosthetic legs have been in use since ancient times. The largest impetus for prosthetics occurs with wars. Major research in prosthetics occurred after World War II when the surgeon general established the first research center that worked toward the advancement of prosthetic devices.3 The immediate postoperative prosthesis (IPOP) was developed in 1967. The IPOP is a rigid cast with a pylon rod and an attached foot applied while in the perioperative period. From the surgeons’ perspective, the IPOP is not widely popular because of the inability to inspect the incision on a regular basis.4 The use of the IPOP has demonstrated many advantages, including improved wound healing, earlier ambulation, shorter hospital stays, and a decrease in the amount of time from the amputation to fitting of a permanent prosthesis. Early research performed on the IPOP focused on wound healing. The stimulus for these studies stemmed from the inability of seeing the created wound. Wound healing with an IPOP was shown to be as good as or better than the control in multiple studies.5–10 The fabrication of immediate or early prostheses has changed with time. An option today is a prefabricated pneumatic prosthesis that is removable. The ability to remove the device has decreased the surgery team’s anxiety of being able to view the surgical incision but there continues to be questions raised of wound healing. Studies have been performed with this type of construction, which found significantly fewer postsurgical complications.5–6
Early ambulation and rehabilitation success is a benefit of application of the immediate prosthesis. In one of the earlier studies by Kihn et al., they studied 182 patients using the IPOP. Outcomes of this study showed a rehabilitation success rate of 84%.11 Similarly, Folsom et al.12 showed a rehabilitation success rate of 85% using an IPOP with all achieving early ambulation. Kane and Pollack8 found that functional recovery of the IPOP patient was greater than that of the non-IPOP patient. Weinstein et al.13 found the IPOP to be successful with an increase in independent gait in 3 weeks. An unpublished study by Malone et al. looked at the outcomes between the IPOP and non-IPOP patients. High rates of rehabilitation with prolonged ambulation of the IPOP population was a major outcome shown in this study.14 Schon et al. evaluated a group of persons with transtibial amputations using an IPOP with a control group. Findings indicated that the IPOP group had a shorter time to permanent prosthesis placement.7
There are many well-documented psychosocial issues that occur in persons with prostheses. A “triple insult” is often suffered by the person with an amputation.15 The insults are loss of function, loss of sensation, and loss or change of body image. There are stages that a person goes through after an amputation ranging from shock to acknowledgement and finally adjustment. The factors that influence adjustment include economic changes or lack of psychosocial support and the preparation time before the amputation. Other factors affecting adjustment are the underlying reason for the disability (trauma vs. disease), the age of the person at the time of the amputation, and the prosthetic rehabilitation a person receives.
Well-being or quality is affected by physical and psychosocial parameters after amputation. Although community reintegration and improved mobility are aims of persons with amputations, optimal quality of life should be among the primary objectives of rehabilitation. Warren and Moseley found that an IPOP placed on transtibial patients yielded better morale of this segment of patients.16 Matsen et al. conducted a research study using the prosthetic evaluation questionnaire (PEQ). One of the result matrices studied was quality of life. The study showed a correlation between satisfaction and the quality of life with complex variables of comorbidities, symptomatology, prosthesis type, and social factors.17 The study did not specify time frame of first prosthesis or whether it was an immediate placement or a temporary prosthesis. A study by Harness and Pinzur measured quality of life in transtibial prosthetic users. The instrument used in this study was the PEQ.18 The outcome of the study was increased satisfaction and well-being with successful prosthetic use. As in the aforementioned study, there was no report of IPOP use in their cohort. A number of studies have been performed on quality of life comparing amputation with limb salvage patients. Outcomes of most of the studies have shown an increase in quality of life and better adjustment when the amputation is complete.19–23 The literature revealed many studies dealing with various aspects of amputation, but no studies that included quality of life between patients who received an early prosthesis in comparison with those who had a traditional prosthesis placement.
Malone et al.14 found that 60% of persons with amputations are rehabilitated successfully. The reasons cited for poor rehabilitation include lack of a team approach and lack of an accelerated rehabilitation program. Many institutions do not use an early prosthetic program because of insurance provider’s unwillingness to pay, belief that the technique is ineffective, and patients not receiving preoperative ambulation level testing.14 Amputations are viewed as a last resort or failure of vascular surgery procedures. The implication of these factors for healthcare providers is to realize that the amputation is not the end to quality of a person’s life. Measuring outcomes in persons who have undergone rehabilitation is often a challenge for health practitioners. Successful outcomes are desired and are multifaceted in nature. The goals of the individual are important. Most practitioners advocate a variety of outcome measures that include quality of life with functional limitations. Mobility with a prosthesis is often a primary objective of rehabilitation programs. Assessments of mobility include performance tests, categories of ambulation, self-reported capability, and prosthetic use in several ambulation activities. Miller et al24 evaluated the questionnaire, “PEQ” developed by Legro et al. in 1998. The PEQ measures the quality of life related to the areas of physical, psychologic, social/role functioning, and well-being.2 The PEQ is one of only a few detailed instruments that measures quality of life and functional outcomes. It has been used in many settings from acute care to biomedical research centers.25 The PEQ scales are not dependent on each other, so that the results can be reported independently.26 The PEQ authors request that credit be given to the Prosthetics Research Study that was funded by the US Department of Veteran Affairs by anyone who uses this instrument.27
Recent literature on quality of life for persons who use prosthetic devices is sparse. Studies using a prefabricated removable dressing dealing with quality of life were not found in the literature.
A descriptive observation and survey design was used to meet the specific aims of this study. The study was conducted as a self-report survey of patients who received a below-the-knee amputation (BKA) from 2001 up until 1 month before study implementation (2005). The survey that was administered was the PEQ. The PEQ was chosen because of its comprehensiveness related to many facets of living with a lower limb prosthesis and its reported validity and reliability.16,28 The questionnaire has nine scales: ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, and well being. It uses a linear analog scale response format accompanied by a 100-mm bound by two anchor phrases denoting the extremes of the possible answers. Respondents indicated their answer by making a mark across the line. For this study, the line was measured from 1–10 using a 10-cm measure. The items were grouped as they are listed on the questionnaire into six groups: functionality, mobility, psychosocial experience, bodily sensations (pain), satisfaction with their prosthesis, and quality of life. The scale has been tested extensively and has demonstrated a high internal consistency with Cronbach’s alphas ranging from 0.73–0.89.2
The “Information Chart for Data Collection from the Medical File” developed by Gauthier-Gagnon and Grise29 to be used conjointly with the PEQ is to collect data related to the medical history and residual limb issues. Permission to use both the scales was obtained from the primary authors. A demographic questionnaire accompanied by a purpose letter, agreement of participation, and instructions was given to the participants with the PEQ and information chart tool. Approval for the study was acquired through the Institutional Review Board at a large southeastern medical facility in the United States.
The first cohort consisted of patients who received a prosthesis within 2 days to 6 weeks after lower limb amputation and later received a traditional prosthesis. The second cohort consisted of those who received their temporary and permanent prosthesis more than 8 weeks after surgery. A convenience sample included all persons aged 18 years and older who received a BKA regardless of reason for the procedure. Sampling included persons who had unilateral and bilateral below knee amputations. Excluded were clients less than 18 years and had received an amputation above the knee or of only digits. The sample was obtained from two free standing prosthetic centers. The clients were approached on return visits to the clinic. Permission to use the clinics was obtained. A clinic roster at the prosthetic center was reviewed for potential participants. The list was called before the set clinic dates and informed that a study would be held during this time. On the date of the clinic, the interviewer assigned to the clinic approached clients that fit inclusion criteria about participation. Informed consent was obtained if the client agreed. The PEQ and demographic sheet were then given to the client to complete. At the end of clinic, the PEQ and demographic sheet were collected before departure of the participant. The interviewer was available for any questions or concerns. A principal investigator was present on site during the clinics but did not participate in the interview process. Two trained interviewers conducted the survey administration.
Recruitment of 37 participants occurred between January 2004 and June 2006 who attended one of four clinic dates. Breakdown of operative limbs was 43.2% right leg, 45.9% left leg, and 8.1% bilateral. The mean age of the control group was 62 years with a mean for the EPOP group of 55. Thirty-one (83.6%) were men and 6 (16.2%) were women. The causes of amputation were as follows: 21.6% trauma, 13.5% vascular disease or nondiabetic, 62.2% vascular or diabetic, and 2.7 tumor related. The dominating comorbidity was diabetes. The control group had a much higher percentage of cardiac comorbidities at 75% versus 36.4% of the study group (see Table 1 for demographics).
Most of the patients received their rehabilitative training at an inpatient setting (67.6%), with the remaining receiving rehabilitative services as an outpatient. Seventy-four percent of the participants were admitted into the inpatient rehabilitation setting from a hospital acute status, with the remainder admitted from an outpatient setting. The number of prosthetic training programs attended by the group was dispersed evenly. Of the total number of participants, 57.1% received one prosthetic training program, whereas 42.9% received more than one. Prosthetic components were relatively consistent with all but one using a total surface bearing socket. Seventy-eight percent were constructed of a pin-locking suspension. Type of foot use varied in relation to functional level from solid ankle, cushioned heel, seattle, multiple axis, other (mostly dynamic response), and flexfoot with respective values of 2.7%, 8.1%, 10.8%, 29.7%, and 48.6% (see Table 2 for prosthetic demographics).
Ambulatory skill at time of discharge was measured in terms of functional independent level. The study categorized skill as independent and not limited 42.9%, independent but limited 37.1%, need supervision not limited and need assistance not limited both 5.7%, and need assistance limited 8.6% (Table 3). Durable equipment for ambulation was not needed for 35.3% of the group. Equipment used by the remainder of the sample was two crutches 2.9%, use of one cane 11.8%, walker 38.2%, and other equipment 11.8%.
Fifteen received the EPOP and 22 received a traditional prosthesis after a period of waiting. The amount of time that prostheses had been used was 2.42 and 2.08 years for EPOP and the control group, respectively. Comparison of the EPOP group and the control group related to ambulatory scale, age, and prosthetic use showed no significant differences (Table 4).
Of the 37 participants, 25 were hospitalized at the time of receiving prosthetic training, nine were outpatient, and three had no data. The multiple training sites with different criteria of instruction were believed to be a confounding variable. A decision was made to look at the 25 participants who attended an inpatient rehabilitation program for stratification. When comparing this group (n = 25) with the total group (n = 37), the groups looked proportionate in demographics and prosthesis make up. Breakdown of hospitalized group for demographics and prosthetic information are summarized in Tables 1 and 2.
In the subgroup of 25 participants, 91% of the EPOP recipients were independent at discharge compared with 61.5% of those with the traditional prosthesis. Twenty-four percent of those with an EPOP needed no technical aids, 8% needed one cane, and 48% needed a walker. However, 75% of this group required more dependence on durable equipment for mobility, such as, a cane, crutches, or a walker, than the traditional prosthetic group (73%). A Chi-square test for independence was used as outlined in the tool as the domain for quality to test for significance. A χ2 test for independence indicated no significant association between independence and the use of an early prosthesis, χ2 (1, n = 25) = 1.67, p = 0.19.
The questionnaire had several scales, and the items were grouped according to the way they were presented on the questionnaire: functionality, mobility, psychosocial experience, bodily sensations (pain), satisfaction with their prosthesis, and quality of life. The means of these scores are illustrated in Table 5.
The functionality or utility scale included items of fit, weight, comfort, ability to balance, and how much energy it takes to use the prosthesis. Also included are satisfaction with the prosthesis and the ease of donning it. The average mean for the EPOP group for these items was 7.12 and for the traditional prosthesis group was 6.89. The survey line of measurement that the participants marked had a score at one end of 10, indicating that the participant was extremely happy with their prosthesis’ functionality and a score of 0, which indicated extreme unhappiness. Overall the participant who had an EPOP was happier with their prosthesis, but the differences between the groups were not significant. The second scale involved bodily sensations. The items included in this scale described painful sensations related to the prosthesis, residual limb, and phantom pain. For these items, a mark on the far right (10) indicated extremely mild pain and a mark on the far left indicated extremely intense pain (0). The EPOP group mean score was 6.28 versus 5.81 for the traditional prosthesis group. The participants with a traditional prosthesis had more pain than those who had an EPOP. The third scale measured psychosocial aspects of having a prosthesis. Items on this scale related to frustration, other people’s response to their prosthesis, and the affect on relationships with their partner and family members. The EPOP group had a mean score of 8.63 and the traditional group had 8.38. A score on the right side indicated “never” response and to the far left indicated “all the time.” The means were statistically the same and indicated that for the groups, frustration, avoidance, and marred relationships, were not immense issues. Scale four measured mobility. Items included were ability to walk with the prosthesis including walking in close spaces, hills, slippery surfaces, and on stairs. In addition, items related to sitting and standing were included. Again the EPOP and traditional group mean scores were statistically similar at 7.78 and 7.44, respectively. Scores to the right indicated “no problem” and to the far left, “cannot” or the inability to perform. The scores indicated that mobility was reported as “no problem” for both groups. Scale five asked about “satisfaction” or well-being of the participant. The questions referred to their prosthetic training postoperatively and their general satisfaction with the prosthesis. A score of 10 indicated “extremely satisfied” and a score of 0 was “extremely dissatisfied.” The mean scores were similar: EPOP, 8.56 and traditional, 8.23. Quality of life was the last scale measured by the instrument. In this section, issues relating to normal daily activities and how these activities were affected by the prosthesis were measured. A score of 10 indicated that the issue was “extremely important” and a score of 0 indicated “extremely bothersome.” The EPOP score was 7.7, and the traditional group score was 7.4. The two groups believed that their prosthesis was easy to manipulate, durable, and functional, with relative ease in their daily life activities.
In this study, quality of life for persons with an amputation(s) who received an early prosthesis was compared with those who had a traditional prosthesis and waited 2 months or more for prosthesis placement. No significant difference was noted between the groups relative to quality of life as defined by the PEQ. The control group of traditional prosthetic participants was older and had more comorbidites than the EPOP group. The control group also had used their prosthesis less time than the EPOP group by 6 months. Although not statistically significant, the study pointed to factors such as age, experience, and comorbidities, could be the reason for successful and early increased independence with a prefabricated prosthetic device. People whose amputation resulted from trauma are younger and have less comorbid factors. This group received the EPOP more often in this study and had better functional long-term outcomes. As Rybarczyk et al.30 reported that stigmatization can be a factor in the quality of life of a person with an amputated leg. For the participants in this study, this did not seem to be a factor by the indication that frustration, avoidance, and marred relationships were not concerning for them.
Of clinical significance, in this study, is the level of independence of those surveyed who had an EPOP during their rehabilitation period. In this group, 91% of the participants were independent on discharge from the rehabilitation program compared with 62% of the traditional prosthetic wearers. The clinical outcome of independence may indicate that the EPOP helps and enhances the rehabilitation process.
Amputation is a devastating event. The ability to maintain a functional status is the goal of both the healthcare professional and the patient. Early ambulation can help the patient with an amputation maintain some level of independence while psychologically dealing with limb loss. To assist patients with independence, an early prosthesis is a feasible option for ambulation in the postoperative and rehabilitation phase.
Quality of life for persons with early prosthetic devices compared with a more traditional waiting period of healing and then manufacturing of a custom fit prosthesis was nonsignificant in this study. Clinical significance was shown to be an outcome with increased independence in the EPOP group.
Limitations of the study included a small sample size and set limitations of exclusion criteria for EPOP use. Not all persons with amputations are considered candidates for an early prosthesis thus limiting the sample size. The persons with traumatic amputations who have fewer comorbidities and are younger are ideal candidates when determining who should be provided with this type of early mobilization device. Success in this group has been well demonstrated in the clinical setting.
Future research needs to continue to assist the amputation patient in early ambulation. Psychosocial adjustment is closely tied to how independent the person becomes after amputation. Independence is necessary for the person to feel that basic needs are met for the patient and their family. The young trauma and war-injured persons would benefit with an early prosthetic placement. Studying quality of life in this group could provide valuable information in this field. The use of early prosthetics for early ambulation assists the young and healthy individual to be less affected by such a devastating loss.
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