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Article

Report on Prosthetic Fitting, Mobility, and Overall Satisfaction after Major Limb Amputation at a German Maximum Care Provider

by
Vesta Brauckmann
1,
Sebastian Mönninghoff
2,
Ole Moritz Block
3,
Frank Braatz
2,3,
Wolfgang Lehmann
3,
Luis A. Pardo, Jr.
3 and
Jennifer Ernst
1,3,*
1
Department of Trauma Surgery, Hannover Medical School, Carl-Neuberg-Straße 1, 30625 Hannover, Germany
2
Orthobionics Study Programme, Private University of Applied Sciences, 37073 Göttingen, Germany
3
Department of Trauma Surgery, Orthopedic Surgery and Plastic Surgery, University Medical Center Göttingen, 37075 Göttingen, Germany
*
Author to whom correspondence should be addressed.
Appl. Sci. 2024, 14(16), 7274; https://doi.org/10.3390/app14167274
Submission received: 30 May 2024 / Revised: 29 July 2024 / Accepted: 14 August 2024 / Published: 19 August 2024
(This article belongs to the Section Applied Biosciences and Bioengineering)
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Versions Notes

Abstract

:
Background: Satisfaction with prosthesis plays a key role in regaining mobility and is important for optimizing prosthetic usage, mobility, and increasing compliance with medical regimen. Despite unchangeable factors like age and comorbidities, other factors, like pain, received rehabilitation, satisfaction with assistive devices, service, and information, can be changed and might contribute to a better usage and acceptance of the prosthesis and amputees’ mobility. Objectives: The aim of the study was to analyze mobility, pain, supply of assistive devices, and additional therapies received after major limb amputations. Furthermore, a correlation of those parameters was evaluated. Methods: Retrospective identification of patients with major limb amputation (operation and procedures classification system (OPS)) and relevant related demographics within the clinical documentation system during a four-year observation time. In addition, we undertook prospective assessment of mobility (K-level), pain qualities, additional therapies, self-rated overall quality of life (QoL) and degree of adaptation to the life after amputation, dependency from caregivers, and satisfaction with the provided assistive devices (QUEST). Results: A total of 164 patients (mean age 68, age range: 19 to 97 years) underwent major limb amputation. A total of 27 questionnaires were returned and analyzed. All those traumatic and nontraumatic amputees received assistive devices. Although mobility and QoL decreased significantly after amputation, a high satisfaction with provided prosthetic and assistive devices and care was found. Conclusions: Amputation registries are becoming elementary to allow for nationwide comparisons of clinics, to identify the requirements of amputees, and to design an interdisciplinary care model for a successful comprehensive approach.

1. Introduction

Limb amputation is one of the most ancient of all surgical procedures, with a history of more than 2500 years dating back to the time of Hippocrates [1]. Amputations are still increasing in many countries due to different underlying patho- and etiologies following challenging economic, psychological, and social impacts. The current epidemiology of lower-limb amputations in many countries is unknown due to the lack of amputation registries even in countries with a high percentage of amputations such as the USA [2]. Almost every clinic amputates, and the major cause of limb amputation varies from one hospital to another. Many etiologies, such as trauma, peripheral vascular disease, tumor, infection, and congenital anomalies, can lead to amputation requiring adapted perioperative and rehabilitative care [3].
The number of abovenamed factors and the heterogeneous etiologies and their implied heterogeneous requirements point to the complexity of the intersectoral care of amputees and might explain the differences in outcomes for amputees between hospitals and received rehabilitation. The significant variability in the quality of care justifies concepts such as comprehensive interdisciplinary care to ensure a standardized approach to caring for amputees and limiting the risks of disparities in access to care and following impacts on the individuum and healthcare system [4,5].
Multiple factors were identified to influence the outcome after lower-limb amputations, including the etiology for amputation, experience of the surgeon, age, sex, education, amputation-related complications, cognitive impairment, comorbidities, mobility before amputation, level of amputation, social environment, access to rehabilitation (fast) prosthetic supply, fast forward mobilization, satisfaction, and daily usage time of the prosthesis [6,7,8,9].
The primary aim in this study was to assess and explore major outcome parameters such as mobility, current pain level and quality, overall satisfaction with the life situation after amputation, and an evaluation of the supply rate and following satisfaction with their assistive devices. This study was performed to identify perceived barriers that lower-limb amputees face in the received standard care of the maximum care hospital, and to use the data to improve the workflow, offer comprehensive patient care, and improve long-term patient outcome.

2. Materials and Methods

2.1. Retrospective Analysis: Amputation Statistics

The study was conducted in accordance with the Declaration of Helsinki. Ethical approval for this study was granted by the local ethics committee of the University Medicine Göttingen. The number of major lower-limb amputation was identified through the SAP (Systems Applications and Products, SAP ERP 6.0) software system encryption using the Operation Procedure Code ((OPS)-code German procedure classification). Included were all patients after major lower-limb amputation. Major was defined as amputation level proximal to the tarsometatarsal joint line (see Supplementary Data S1. OPS Codes) during a four-year observation time at a German maximum care provider. Then, relevant demographic and amputation-related available data from patient files were collected and matched in tabular form. Assessed factors were following age, gender, address, amputation date/etiology/amputation side and level.

2.2. Prospective Data Acquisition and Analysis

A questionnaire (German version available upon request) was sent to the identified amputees a minimum of two (latest in) to five years (first in) after their major limb amputation to assess further parameters (see below). Eight weeks later, the amputees with pending response received a reminder call and, if needed, the questionnaire was sent again. Those amputees were asked via phone to complete the survey, and help was offered to solve comprehension difficulties if needed. After a further three months, data collection was closed. All amputees responding were called to clarify answers and fill in remaining gaps in the questionnaire. To standardize this step, a second questionnaire was added (German version available upon request).

2.3. Assessed Parameters

  • Sociodemographic data: Sex, age at amputation of the amputees for reidentification. Level of the amputation, time until wound healing of the residual limb, and time passed until first fitting with a prosthesis.
  • Prevalence of phantom limb pain (PLP) and/or residual limb pain (RLP) (yes/no).
  • Mobility before and after amputation (K-level classification (Medicare Functional Classification Levels, MFCL) [9,10]; numbers of assistive devices before and after amputation.
  • Quality of life (QoL), herein assessed by six nonstandardized questions consented to and designed by three senior amputations surgeons which rated, based on their expert opinion, the following items as mainly contributing to QoL: autonomous usage of a car (yes, no); enjoying going for a walk (yes, no); overall self-rated quality of life (QoL) and degree of adaptation to the new life situation after amputation (each 3-point Likert Scale); type (spouse, children, care services) and frequency of support.
  • Assessment of additional therapies (physiotherapy, massages, rehabilitation sport, psychological support, pain management, and their evaluation helpful (yes/no).
  • Satisfaction of received information, education about their prosthetic fitting, existing problems with the cost coverage of the prosthesis (yes/no).
  • Evaluation of satisfaction with assistive technology and service: Satisfaction with assistive technology was evaluated with the validated and standardized Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire [11,12].

2.4. Statistical Analysis

The statistical analysis was performed using MATLAB (The MathWorks, Inc., Natick, MA, USA). A correlation analysis was performed using Pearson’s linear correlation coefficient with a value range from r = −1 (perfect negative correlation) to r = 1 (perfect positive correlation), with 0 meaning no correlation between datasets.
Overall self-rated QoL was correlated to mobility after amputation (K-level), degree of adaptation capacity to the new life situation, and satisfaction with received assistive technology (QUEST) and overall prosthetic care. Furthermore, adaptation capacity to the new life situation was correlated to satisfaction with received assistive technology (QUEST) and overall prosthetic care and the K-level after amputation to the time passed until first prosthetic fitting. A p-value < 0.05 was considered statistically significant. Identically, the correlation analysis was run between adaptation to the new life and beforementioned items (K-level, assistive device and care satisfaction). Lastly, we analyzed the correlation between the K-level and the time until prosthetic fitting. The correlation analysis was performed in both the traumatic and nontraumatic groups to detect differences between the groups.

3. Results

3.1. Sociodemographic Data, Response Rate, Etiology, and Amputation Level

See Table 1. A total of 164 patients underwent 199 major amputations in the three-year observation time. The male–female ratio was 72% vs. 28% at a mean age 68 years (range: 19 to 97 years). Trauma vs. nontrauma ratio was 12% vs. 88%.
At a minimum of two years to a maximum of five years after their major limb amputation, the questionnaire was sent out to 119 patients. Out of 164 patients, 45 (27%) died within five years after amputation. A total of 49 out of 127 patients (30%) refused to participate in the study. We were not able to reach 45 patients (27%). Potential reasons could include movement, nondocumented death, no reason, etc. Finally, 27 patients (17%) took part in the survey (Scheme 1).
The mean age of the 27 participants was 65 years (range: 38 to 82 years) with a gender distribution of 3:1 (men/women). Two patients received an amputation of the hind foot (7%), 13 (48%) received a below-knee amputation (BKA), 5 (19%) underwent a knee disarticulation, and 3 (11%) received an above-knee amputation (AKA). Two participants (7%) were bilateral amputees. Amputation due to trauma occurred in seven patients (25%) and was, for all, the final consequence of a traffic accident.

3.2. Mobility before and after Amputation

Overall, 17 patients (63%) were very mobile before the amputation and reported being unrestricted outdoor walkers (K-level: 3–4). Four of these assigned themselves to mobility level K4. Nine other patients rarely moved outside even before the amputation, and one patient indicated that, despite several assistive devices, his mobility was very limited, even indoors. After amputation, all patients showed a reduction in mobility. The number of unrestricted outdoor walkers decreased from 17 to 5 patients. Consequently, most patients (63%) were indoor walkers after amputation. Although no patient was completely unable to walk (K-level 0) before amputation, four patients reported not being able to walk on their prosthesis after amputation. On average, the mobility level before amputation was 2.7 (±0.7). This value decreased to 2.2 (±0.6) after the amputation, requiring another assistive device to commute. See Figure 1.
A total of 10 of 20 patients suffering nontraumatic amputation were unrestricted outdoor walkers (K levels 3–4), and no patient was completely unable to walk before amputation (K-level 0). Two achieved K-level-3 mobility and four amputees were unable to ambulate and rated their mobility at a mobility level of K0 after amputation. Within the subgroup of the traumatic amputees (N= 7), none of the participants reported a restriction in mobility prior to the trauma. After amputation, only three were still able to move outdoors without any restrictions (K-level 3 and 4). Three were classified K-level 2. No one reported a complete loss of mobility (K0).

3.3. Overall Self-Rated Quality of Life (QoL) and Adaptation to Life after Amputation, Kind and Frequency of Support from Caregivers, and Prevalence of Amputation-Associated Pain

See Table 2. A total of 23 patients (85%) enjoyed outside walking before the amputation. This number reduced to about half after the amputation (N = 12, 44%). A total of 60% (N = 16) were able to drive their car independently even after the amputation. The remaining 40% (N = 10), however, were not able to drive their car. Interestingly ten amputees who were able to drive their car also liked to go for a walk. A total of 22% of the amputees (N = 6) did not need any assistance in everyday life and were able to manage independently in everyday life. A total of 78% (N = 21) were dependent on assistance from their spouses or from social services. Seven amputees needed this help up to twice a day, while eight patients were already unable to carry out their activities without the help of a third party up to five times. Six amputees were constantly dependent on help from a third party (partner).
Due to the consequent substantial changes of life after amputation, the patients’ ability to adapt to life after adaptation was also analyzed. One of the 27 survey participants (4%) has not yet been able to adapt to the new living situation and consequently has major problems in everyday life. This patient reported to be constantly dependent on help and assistance from a third party (partner). Six amputees (22%) reported to have had adapted completely to their living situation. Only one participant showed no capacity to adapt to the amputation-related life circumstances. This amputee needs constant assistance.
The majority (74%) of the amputees (N = 20) have adapted to the new circumstances as far as possible and accept the need for regular assistance and support from a third person. A total of 44% of the amputees (N = 12) felt severely limited and a further 19% (N = 5) considered the limitation to be average when they were asked to rate their overall QoL after amputation. Eight patients (30%) declared low limitations and two (7%) reported that the amputation has no impact on their life’s QoL.

3.4. Pain, Additional Therapies, and Their Self-Rated Evaluation

Most of the patients (N = 20, 74%) received physiotherapy. Less than 50% had rehabilitation sports or had massage therapy. Less than 10% received psychotherapy or were connected to a pain ambulatory even though 70.4% of the amputees (N = 19) reported having phantom limb pain (PLP); in comparison, 42.3% reported residual limb pain (RLP) (N = 11) (Table 3). All who received additional therapies regarded them as helpful (Table 4).

3.5. Amputees’ Evaluation of Received Information and Education about Their Prosthetic Fitting

We found that only 25% of the amputees felt like they were provided with sufficient information, and only 40% reported being provided with a variety of offers regarding the prosthetic fitting. However, over 90% reported being satisfied with the care from their orthotist as well as family doctor (Table 5).

3.6. Supply with Assistive Devices Including Prosthetic Fitting

A total of 26 of the 27 patients (96%) reported to be fitted to a prosthesis. One patient’s (hind foot) amputation was supplied with orthopedic footwear and further assistive devices, such as a walker, walking stick, and a wheelchair.
In most cases, prosthetic fitting was initiated quickly but limited by the wound healing process, which took up to six weeks until being completed, according to the answers. Nine amputees underwent their first trial fitting of the prosthesis as early as four weeks after amputation and were able to begin gait training and further rehabilitative exercise. The start of the first trial fitting of the majority of the patients ranged between 8 and 28 weeks due to various factors (revision surgeries such as scar corrections, infections, and prolonged wound healing). In one case, the health insurance refused to approve the cost coverage and thereby prolonged the initiation of the prosthetic fitting process. As a result, the average time until first prosthetic fitting, defined as first time walking on the interim prosthesis, was 11 weeks (±6.85) (N = 26).
Only 20 participants of the survey gave any information about their prosthetic components in the questionnaire. A total of 45% (N = 9) were able to provide the name of the manufacturer and 55% (N = 11) were able to provide further information about their exact prosthetic components. During the second telephone call, the interviewer could clarify that 25% of the AKA and knee-disarticulated amputees (N = 8) were fitted with a mechanical and 38% reported being fitted with a microprocessor-controlled prosthetic knee joint. The remaining AKAs and knee-disarticulated amputees could not provide information about their knee joint or be reached by telephone. The survey revealed even less knowledge about prosthetic feet components. While 25% (N = 5) of the 20 patients use a carbon foot, one a Bellmann prosthesis, and another one orthopedic shoes, the majority 65% (N = 13) could not give details about their prosthetic foot component.
Eight patients (40%) received a second (N = 6) or even a third additional prosthesis (N = 2). These patients received bathing prostheses (N = 6) and one a sport prosthesis (N = 1). Two patients (10%) used a former outdated prosthesis as a replacement prosthesis to “get to the supply store in emergency cases”. More than half of the patients surveyed (60%) did not receive a second prosthesis as they expressed “no need” or “not even knowing that they could get a second prosthesis”. Two did not receive a second prosthesis, although both would like to have a bathing prosthesis as the health insurance company did not approve it.
Fifteen amputees (56%) wore their prosthesis on average up to eight hours a day. All others reported difficulties, with a maximum wearing time of four hours daily (N = 10). Two (7%) participants stated that they were not able to wear their prosthesis at all (Figure 2).
A total of 26 amputees (96%) needed or were supplied with at least one further assistive device (Figure 2). In contrast, only five amputees (18%) needed to use an assistive device prior to the amputation. The dependence on assistive devices, mainly walking aids (23 out of 37 assistive devices), increased after amputation to an average amount of 1.4 assistive devices/amputee.
Six patients required an assistive device before amputation. However, the majority (about 78% (N = 21)) did not need any of them substantially for independent locomotion. The number of needed assistive devices increased by 30 after amputation. Thus, 96% (N = 26 of 27) required an assistive device in addition to their prosthesis after their amputation. A total of 26 out of 27 patients received at least one further assistive device, and five amputees were dependent on two to four other assistive devices.
Walkers and forearm crutches were the most common assistive devices used by patients within the survey, with eight each. Seven patients used a walking stick or used a wheelchair to ambulate safely. The use of a lift (N = 4) or a commode chair (N = 2) postoperatively was seldom. On average, each patient was dependent on about 1.4 assistive devices (±0.88) after the amputation (see Figure 3).

3.7. Evaluation of Satisfaction with Assistive Technology and Service Results of the QUEST

The overall satisfaction with the assistive device(s) including, according to the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0, [11]), variables of effectiveness, comfort, ease of use, durability, safety, adjustments, weight, and dimensions (see Figure 4), was 3.9 and 4.3 for service (repairs/servicing, follow-up services, professional service, and service delivery), summarizing to an overall satisfaction of 4.1.
More than 50% were quite satisfied (4) or even very satisfied (5) with their assistive device(s). In particular, adjustments were satisfactory for most of the amputees (N = 20, ±1.1). The dimensions and ease of use were rated as “very satisfied” by 48% of patients (N = 13) (±0.9; ±1.2). Less than one-third were moderately satisfied. Major points of criticism were high weight (N = 9) (±0.94) or the comfort (N = 8) (±0.99). Five patients expressed high dissatisfaction with their assistive device. These complained about the weight, comfort, and also the effectiveness of the devices, among other issues. Therefore, they rated the received assistive devices with an average grade ranging from 2.6 (±0.5) to 1.5 (±0.9). Due to wound healing disorders, one patient was provided with a simple wheelchair for a long time, which did not offer satisfactory mobility.
An overall high satisfaction was reported for the services, including follow-up services and the professional service of the entire rehabilitation team. A total of 85% (N = 23) were fairly or very satisfied with the services. It should be noted that one patient did not participate in this part of the survey and one patient provided incomplete information. The amputees who were rather dissatisfied with the service delivery had to wait to be fitted between a minimum of 12 and a maximum of 28 weeks. Surprisingly, this subgroup rated the professional service (N = 14) and follow-up services (N = 12) very high (4 and 5). Overall, the rating of the service by all patients was about 4.3 out of a possible 5 points. Three patients stated that they had had moved to another medical supply store because of their unreliability (see Figure 5).
The adjustment ability of the assistive devices was among the most important items for about half (N = 12) of the amputees when they were asked to weigh the importance, following professional service (N = 11), safety (N = 10), and effectiveness of the assistive devices (N = 9), for at least 36%. However, for eight patients, the dimensions of the assistive devices (N = 2) and the weight and durability (N = 3 each) were also of primary importance. Interestingly, we could observe concordance, as the amputees with a higher overall dissatisfaction weighted the items they were not satisfied with conclusively as important, which might show their capacity for differentiation within the whole supply chain.
During the telephone call interviews, the majority of amputees commented on being extremely satisfied with the clinical care and the communication between the hospital and the medical supply stores to ensure smooth and prompt care. Thus, the delay was mainly restricted by the wound healing problems (N = 8).

3.8. Correlation Analysis

Within the traumatic amputees subgroup, stronger correlations were seen between overall self-rated QoL and mobility, QoL and adaption capacity to the new situation after amputation, and between QoL and satisfaction with the assistive device, compared to the nontraumatic group. Overall, a positive correlation was found between QoL and satisfaction with the assistive device in the traumatic group. A positive correlation was also found between adaption to the new life situation after amputation and QoL in the nontraumatic group.
A strong correlation was observed between the degree of adaptation capacity to the new situation after amputation and K-level, as adaptation capacity to the new situation after amputation and satisfaction with the assistive device (Table 3), letting us assume that higher K-levels and satisfaction with the assistive device lead to a higher degree of adaption to the new life situation after amputation. No correlation between a higher degree of mobility (K-level) and the time in weeks that amputees waited for their first fitted prosthesis could be obtained for traumatic (p = 0.287) or nontraumatic amputees (p = 0.633) (see Table 6).

4. Discussion

4.1. Demography

For decades now, studies have shown an increasing risk of amputation among older patients and commonly with amputees older than 60 years [13,14,15]. Herein, 74% of the patients (N = 122) were over 60 years old, and 90% of the included amputees ranged between 50 and 90 years.
In concordance with the previous literature, we observed a higher number of amputees being male. While the incidence of serious traumatic injuries is generally higher among men, the number of men in traumatic amputations is accordingly higher than of women [16,17,18]. However, nontraumatic amputations occur more frequently in men, too [19].
Herein, the overall cohort size and size of the subgroup did not allow for reasonable gender-related correlations.

4.2. Amputation Level

Herein, the ratio between amputations of below the knee joint amputations (BKA) (54%) and above the knee joint amputations (32%) was 1.7:1. In contrast, a significantly greater trend towards BKA was observed in the USA (ratio: 2.7:1). In Germany, the number of major amputations decreased by 30% and the number of minor amputations increased by 25.4% [13,20]. The ratio from all German medical institutions between 2015 and 2019, provided by the Federal Statistical Office of Germany (Destatis), is lower, at 1.4:1 [21].

4.3. Response Rate and Mortality

At the time of the evaluation, two to five years after the amputation had passed. Mortality rates after major limb amputations for nontraumatic amputations show rates up to 70% at 5 years follow-up [22] as major limb amputation is mainly a symptom of a systemic disease; thus, the mortality rate ranging between 32 and 59% in this study population is representative. One limitation within this study remains, which is that this study lacks a time-based analysis of the measured parameters.
The response rate to the questionnaire after five months was lower than expected (27 amputees, 16%). A total of 25% of the responders were traumatic amputees representing the 12% of traumatic amputees of the original cohort. A total of 75% of the 27 responding amputees were nontraumatic. The low response rate might be explained by the high abovenamed mortality rates among nontraumatic amputations.
Another reason could be the conception of the study. We tried to reduce conceptual limitations such as overall length and design of the questionnaire (see below). We limited the questionnaire to 13 pages by concentrating on relevant questions to QoL instead of standardized questionnaires, and we used a comfortable font size (Arial 14).
The study’s findings are constrained by the small cohort size (N = 27), which limits the scope of interpretations. However, it should be noted that the participants, who were at least two years into their rehabilitation process, may offer a somewhat representative sample as they were unbiased by past experiences. It should be noted that this study did not include an intervention arm.

4.4. Prosthetic Supply, Assistive Devices, and Mobility

All responding amputees were fitted with a prosthesis. Almost all amputees (N = 26) needed one further assistive device in addition to their prosthesis. The additional need for assistive devices could be due to the overall rather low level of mobility. Other studies reported comparable dependency on further assistive devices to achieve independence and safety in everyday life locomotion [23]. Those results affirm the importance of the supply beyond the prosthetic device.
The association between prosthetic use and physical activity is an important subject to discuss [24]. Herein, 55% (N = 15) of the amputees used their prosthesis up to eight hours a day and 8% (N = 2) did not use the prosthesis at all. Other investigations report that 40% of patients used their prosthesis between 6 and 16 h a day [23] and less than 20% of the study participants did not use prosthetic provision at all, or only rarely [25]. Even though the overall mobility of both patient groups decreased after the amputation, the regained mobility in trauma patients was higher. Although four out of seven patients had reached a mobility level of K2 after amputation, none dropped below that level. In contrast, four patients (20%) with a nontraumatic cause of amputation were no longer able to walk at all after the amputation (K-level 0), most probably limited by their accompanying comorbidities and age. Therefore, mobility post-amputation is mainly related to, or even determined by, mobility prior to amputation, and this implies accompanying underlying systemic disease [26,27]. Thus, those determining factors should be identified, and other medical disciplines, such as internal medicine, should be involved in amputation care to address the underlying pathologies limiting mobility. Furthermore, concepts described as prehabilitation might be integrated in an amputee care concept. The term prehabilitation describes all interventions aiming to improve a person’s functional capacity, as well as tolerance to possible future physiological stress, such as surgical interventions [28]. Prehabiliation has not yet been a focus of research regarding major lower-limb amputation [19].
The finding that there was no relationship between the final K-level and the time that passed until prosthetic fitting was quite unexpected. We expected a strong correlation between a high K-level and shorter time until prosthetic supply, since reports in the literature have shown that earlier prosthetic fitting can lead to quicker ambulation and walking ability [29,30]. Again, this study lacks a time-based analysis of the measured parameters, especially mobility outcome parameters, which can change over time during rehabilitation.

4.5. Relations of Quality of Life, Adaption to the New Life Situation, Mobility, and Satisfaction with the Assistive Devices (QUEST)

Even though we found that self-rated QoL was mostly reported to be severely limited due to the amputation, the self-rated adaptation to the new situation was mostly satisfactory in the analyzed cohort (largely adapted, 74%, N = 27).
The correlation analysis revealed overall high satisfaction for both traumatic and nontraumatic patients with the devices and service, indicating higher adaptation to the new situation if good service and satisfying assistive devices were received. The correlation analysis for QoL correlated negatively with K-level, adaptation to the new life situation, and satisfaction with the device and services. Within this study, for amputees with AKA and knee disarticulations, impact on QoL was not relevant when compared to amputees at more distal amputation levels. This is congruent to other studies showing no correlation between satisfaction measured by the QUEST questionnaire and amputation levels [31]. Due to the limited number of study participants, it was not possible to discern possible reasons. Maybe this could be explained by the finding that advanced mobility skills including outdoor walking could still be reached using a reliable, safe prosthesis and required assistive. As for additional therapies, all were regarded as helpful; 74% of the study cohort received physiotherapy but only 33% participated in rehabilitation sport. However, the presence and characteristics of a specific prosthetic rehabilitation protocol were not assessed in this study, which might be a further important factor influencing the overall (functional) outcome [4,5,7]. Even if our data consisted of discrete variables, we decided to use linear regression lines, without forecasting character but aiming for better visualization of the degree of correlation. Generally, there are many possible scores that can be used to measure QoL, with high variations due to complex interactions of physical function and psychological comorbidities [6,7,32]. It is important to note that even though 44% stated to be severely limited in the QoL, the majority of participants (96%) felt largely or even completely adapted to the new life situation after amputation.
There are multiple questionnaires with different approaches to assess satisfaction with the prosthetic devices [33,34,35]. The herein used QUEST 2.0 questionnaire evaluates the degree of satisfaction with assistive technology devices from the user’s perspective [11]. Overall satisfaction is the result of multidimensional, dynamic constructs. The subjective evaluation of a limb replacement, including the emotional perception, seems to be influenced by factors like appearance, properties, fit, use, and interaction with the residual limb, as well as pre-existing emotional predispositions of the amputee. Therefore the satisfaction with the prosthesis can be described as a bio–psycho–social construct, contributing to the overall quality of care [31,32,35,36,37,38,39,40,41]. Furthermore, amputees’ satisfaction is the offset of their continuous experience and their expectations of healthcare services, including experienced management of the healthcare budget [31,32,33,34,35,36,37,38]. Interestingly, amputees were generally more satisfied with the services than with the prosthetic devices.
The German guidelines for rehabilitation after major lower-limb amputation defines minimum goals 14 days after the prosthetic fitting, such as independent ability of donning the prosthesis, pain-free fitting, and safe and independent mobilization with an assistive device [41]. This is congruent to other investigations using the QUEST and highlighting comfort, effectiveness, and ease of use [42]. We agree that those goals allow for satisfaction, mobility, and safety and are fundamental for the acceptance of the physical impairment, but also for the long-term rehabilitation, including adaptation at a satisfying QoL. Worse outcomes in overall mobility have been associated not only with a worse QoL, but with preceded cognitive concerns and overall activity [43]. One of the main objectives in rehabilitation is regaining mobility, in which satisfaction with the prosthetic device is a major factor as it enables mobility [33]. From the previous literature, we know that the higher the mobility of amputees, for example, due to participation in mobility programs [44] or even due to more advanced prostheses [45], the higher the satisfaction in the QUEST questionnaire is stated to be. It has been shown, furthermore, that independence is very valued and expressed by activities, commonly regarded as mundane, such as being able to go for a walk or driving a car [15]. The design of this study placed the focus on substantial mobility and patients’ evaluation of their assistive-device-related quality of care, which is why our QoL questionnaire was adapted to the ability of mundane but elementary activities (go for a walk, driving a car), kind and frequency of support by caregivers, and overall self-rated degree of adaption to the new life situation [31,32,33,34,35,36,37,38].
Furthermore, the social impact (e.g., return to work) of amputation and its influence on satisfaction and the rehabilitation process should be assessed and addressed in the future [8]. The discussion underlines, once more, the importance of comprehensive prosthetic and assistive device supply after amputation and [20,40] the necessary paradigm shift in lifelong amputee care. Lately, we are observing the transition to an interdisciplinary care model for amputees’ that recruits services focused on functional and psychosocial rehabilitation to offer comprehensive care by addressing the needs of a challenging patient population [46,47].

5. Conclusions

Amputees’ satisfaction with their prosthetic and assistive devices is key for regaining mobility and reaching rehabilitation targets. To increase patient compliance with medical regimen, prevent rejection, and optimize prosthetic use, it is of importance to empower amputees in their new body image, including prosthetic devices [37,38]. Therefore, satisfaction with the assistive devices was chosen to be one major outcome criteria of the analyzed current standard of care. Within this study, we aimed to identify further factors influencing the beforementioned satisfaction and mobility of the current amputee care at our clinic.
In this representative study cohort of amputees, the informative value is still limited due to a low response rate, which shows the necessity for established structures such as specialized consultations with continued comprehensive care and interdisciplinary networks with continually growing amputation registers. We believe that the key to success is interdisciplinary teamwork to formulate an integrated and coordinated treatment plan. Medical, surgical, and rehabilitative care need to subspecialize, meeting the requirements of our patients and varieties of prosthetic components available on the market as opposed to multiple independent plans. Experience from other fields of medicine such as oncology and endoprosthetic orthopedic surgery have shown the value of forming centers of excellence for special intersectoral care to successfully target the overall care and changeable factors affecting satisfaction with the new life situation.

Supplementary Materials

The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/app14167274/s1, Supplementary Data S1: OPS Codes. Supplementary Data S2: Relevant items of the approved questionnaire.

Author Contributions

Conceptualization, J.E., V.B. and O.M.B.; methodology, J.E.; software, L.A.P.J.; validation, J.E., S.M., O.M.B., L.A.P.J., F.B. and V.B.; formal analysis, S.M. and V.B.; investigation, O.M.B. and S.M.; resources, J.E.; data curation, O.M.B. and S.M.; writing—original draft preparation, J.E. and V.B.; writing—review and editing, J.E., V.B., W.L. and F.B.; visualization, L.A.P.J. and J.E.; supervision, J.E. and F.B.; project administration, J.E. All authors have read and agreed to the published version of the manuscript.

Funding

This research received external funding from the Ottobock SE & Co. KGaA (project “MOBILISE-N”, Advanced Clinician Scientist Group), funding number 19420239.

Institutional Review Board Statement

This study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of the University Medicine Göttingen 20/4/17 on 30 January 2018.

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patients to publish this paper.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author, upon reasonable request.

Conflicts of Interest

The authors declare no conflicts of interest.

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Applsci 14 07274 sch001
Scheme 1. Flowchart illustrating the process of subject inclusion and outcomes for 164 patients who underwent 199 major amputations over a five-year observation period.
Scheme 1. Flowchart illustrating the process of subject inclusion and outcomes for 164 patients who underwent 199 major amputations over a five-year observation period.
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Figure 1. Comparison of traumatic and nontraumatic mobility before and after amputation using K-level classification (Medicare Functional Classification Levels, MFCL) [9,10].
Figure 1. Comparison of traumatic and nontraumatic mobility before and after amputation using K-level classification (Medicare Functional Classification Levels, MFCL) [9,10].
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Figure 2. Prosthesis wearing time per day.
Figure 2. Prosthesis wearing time per day.
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Figure 3. Type and number of additional devices before and after amputation.
Figure 3. Type and number of additional devices before and after amputation.
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Figure 4. Satisfaction using a 5-point Likert scale with the assistive technology including following variables: Effectiveness, comfort, ease of use, durability, safety, adjustments, weight, and dimensions, QUEST 2.0 [11].
Figure 4. Satisfaction using a 5-point Likert scale with the assistive technology including following variables: Effectiveness, comfort, ease of use, durability, safety, adjustments, weight, and dimensions, QUEST 2.0 [11].
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Figure 5. Satisfaction with the services according to the QUEST 2.0 variables: Follow up services, professional assistance, repairs/servicing, service delivery. Amputees 10 and 20 did not answer this part of the survey because they could not decide on three items. They saw the overall care and handling of the assistive devices as important in general and therefore could not give a weighting, as the telephone interview revealed.
Figure 5. Satisfaction with the services according to the QUEST 2.0 variables: Follow up services, professional assistance, repairs/servicing, service delivery. Amputees 10 and 20 did not answer this part of the survey because they could not decide on three items. They saw the overall care and handling of the assistive devices as important in general and therefore could not give a weighting, as the telephone interview revealed.
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Table 1. Sociodemographic data, N = 164, total study population. N = 27 active participants (PAD = peripheral arterial disease, BKA = below-knee amputation, AKA = above-knee amputation).
Table 1. Sociodemographic data, N = 164, total study population. N = 27 active participants (PAD = peripheral arterial disease, BKA = below-knee amputation, AKA = above-knee amputation).
ItemsTotal (N = 164)%Total (N = 27)%
Gender
Male11872%2074%
Female4628%726%
Age (mean, range)68 years (19–97)65 years (38–82)
Male67 years (19–90)
Female70 years (38–92)
Traumatic amputation2012%726%
Nontraumatic amputation14488%2074%
Amputation level
Foot2517%27%
BKA4631%1348%
Knee2517%519%
AKA4631%311%
Bilateral117%27%
Mortality4527%
Table 2. Results (% N = 27) of self-rated quality of life and adaptation to the new situation.
Table 2. Results (% N = 27) of self-rated quality of life and adaptation to the new situation.
ItemsTotal (N = 27)%
Dependence on others
0–2 times a day622%
3–5 times a day 1452%
Constantly726%
Enjoyed to go for a walk1244%
Independent driving (car)1659%
Self-rated degree of adaptation to the life after amputation
No14%
Largely2074%
Completely522%
Overall self-rated of QoL
No limitations 27%
Low limitations830%
Average limitations519%
Severe limitations1244%
Table 3. Prevalence of amputation-associated pain (N = 27).
Table 3. Prevalence of amputation-associated pain (N = 27).
ItemN (Total N = 27)Yes, N = x (x%) No, N = x (x%)
Phantom limb pain2719 (70.4%)8 (29.6%)
Residual limb pain2611 (42.3%)15 (57.7%)
Table 4. Prevalence of additional received therapies and their evaluation (N = 27).
Table 4. Prevalence of additional received therapies and their evaluation (N = 27).
Therapy N (N 27 = 100%)Rated as Helpful
Physiotherapy20 (74%)100%
Massage10 (37%)100%
Psychotherapy2 (7.4%)100%
Support Group0-
Rehabilitation sport9 (33.33%)100%
Pain ambulatory1 (3.7%)100%
Table 5. Dichotomous yes/no questions regarding amputation related support, prosthetic care, education, and information.
Table 5. Dichotomous yes/no questions regarding amputation related support, prosthetic care, education, and information.
ItemN (Total N = 27)Yes, N = x (x%) No, N = x (x%)
Sufficient overall amputation-related information2418 (25.0%)6 (75.0%)
Sufficient further offers around the topic of prosthetic fitting2510 (40.0%)15 (60.0%)
Problems with cost coverage255 (20.0%)20 (80.0%)
Satisfaction with care received by the prosthetist2624 (92.3%)2 (7.7%)
Satisfaction with help of the family doctor2624 (92.3%)2 (7.7%)
Table 6. Results of the correlation analysis as indicated by differentiation between traumatic and nontraumatic amputations. r = Pearson’s linear correlation coefficient.
Table 6. Results of the correlation analysis as indicated by differentiation between traumatic and nontraumatic amputations. r = Pearson’s linear correlation coefficient.
Traumatic Amputation CohortNontraumatic Amputation Cohort
Quality of life vs. K-levelr = −0.652p = 0.113r = −0.367p = 0.111
Quality of life vs. adaptation capacityr = −0.716p = 0.071r= 0.551p = 0.012
Quality of life vs. device satisfactionr = −0.824p = 0.023r = −0.160p = 0.501
Quality of life vs. care satisfactionr = 0.621p = 0.137r = −0.006p = 0.979
Adaptation to new life situation vs. K-levelr = 0.745p = 0.054r = 0.222p = 0.347
Adaptation to new life situation vs. device satisfactionr = 0.866p = 0.012r = 0.399p = 0.081
Adaptation to new life situation vs. care satisfactionr = 0.771p = 0.043r = 0.310p = 0.184
K-level vs. time passed until first prosthetic fittingr = −0.470p = 0.287r = 0.114p = 0.633
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Brauckmann, V.; Mönninghoff, S.; Block, O.M.; Braatz, F.; Lehmann, W.; Pardo, L.A., Jr.; Ernst, J. Report on Prosthetic Fitting, Mobility, and Overall Satisfaction after Major Limb Amputation at a German Maximum Care Provider. Appl. Sci. 2024, 14, 7274. https://doi.org/10.3390/app14167274

AMA Style

Brauckmann V, Mönninghoff S, Block OM, Braatz F, Lehmann W, Pardo LA Jr., Ernst J. Report on Prosthetic Fitting, Mobility, and Overall Satisfaction after Major Limb Amputation at a German Maximum Care Provider. Applied Sciences. 2024; 14(16):7274. https://doi.org/10.3390/app14167274

Chicago/Turabian Style

Brauckmann, Vesta, Sebastian Mönninghoff, Ole Moritz Block, Frank Braatz, Wolfgang Lehmann, Luis A. Pardo, Jr., and Jennifer Ernst. 2024. "Report on Prosthetic Fitting, Mobility, and Overall Satisfaction after Major Limb Amputation at a German Maximum Care Provider" Applied Sciences 14, no. 16: 7274. https://doi.org/10.3390/app14167274

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