Because of the development of limb salvage surgery combined with preoperative and postoperative chemotherapy and radiotherapy managements, lower-limb amputation is no longer the only curative treatment for patients with major bone tumors, and it is usually indicated only in patients with large tumor, nerve infiltration, recurrence, or infection after primary surgery. Previous health-related quality of life (QOL) reviews could not find a clear difference between patients after lower-limb amputation and patients after limb salvage surgery for tumor treatment.1 However, experimental measurements of walking indicate compromised walking efficiency compared with those after limb salvage surgery and healthy subjects.2 This point needs to be addressed to optimize functional outcomes after lower-limb amputation for oncologic diseases.
Patients who undergo amputation for cancer treatment are generally diverse, including younger people, compared with those for other pathologies (peripheral vascular diseases or diabetes mellitus).3 Earlier return to their lives is crucial to continue their education and work. Postoperative chemotherapy and possible negative prognosis can disrupt the rehabilitation intervention, make the condition of the residual limb unstable, and cause general deconditioning with cancer-related fatigue. These characteristics make the postoperative rehabilitation for these patients, including delivery of the prosthesis, more complicated.
One possible approach for this situation is earlier introduction of a temporary prosthesis, which can prevent complications4 and shorten the time before fitting of definitive prosthesis.5 The other expected advantages of the earlier use of the prosthesis include alleviating deconditioning,6,7 reducing edema6 to facilitate wound healing,7 and psychological support by earlier mobilization.7 These advantages will help patients with cancer to adapt more easily to their new lives with prosthesis and to continue their social activities.
Several devices, called early walking aids, were developed for this purpose: the Pneumatic Post-Amputation Mobility aid6,8,9 (Ortho Euro, UK), the Saarbrucken prosthesis10 (Ottobock, Germany), the Amputee Mobility Aid,11 and others.12–16 In considering the characteristics of these devices, some disadvantages can be found for each of them: the specificity for the level of amputation, their adaptability to the size of the patients and residual limb (in particular, height), the possibility of modifying the foot axis to achieve a more natural gait pattern, and the dimension of the top ring creating friction with the other limb.
To further optimize the early introduction of a prosthesis for patients after amputation, we developed an original supporting frame for commercial pneumatic bag that can be used universally by individuals with transtibial or transfemoral amputations with adjustable modular components. No articulation of the device was introduced as, based on a previous study,17 no difference in clinical and QOL outcomes between articulated and nonarticulated early walking aids in rehabilitation of participants with transtibial amputations was demonstrated (Table 1).
In this study, we assessed the feasibility of using the original device and its safety in a group of oncological patients with amputations, within the usual rehabilitation program.
Preoperatively, patients who would undergo amputation were referred to the physiatrists to evaluate the eligibility to participate to this feasibility study. Inclusion criteria were no neurologic or cardiovascular pathologies impeding rehabilitation and age between 18 and 75 years. We recruited 15 patients (8 men and 7 women; mean age, 47.9 [range, 18–73 years]), 10 patients after transfemoral amputation and 5 after transtibial amputation for oncological treatment. Mean (SD) follow-up after amputation was 21.1 (3.6) days (T1: wearing the new device) and 90 (54) days (T2: with their prosthesis; 2 patients were not able to come for the T2 follow-up for oncological problems).
The feasibility study was approved by the Istituto Ortopedico Rizzoli Ethical Committee and written informed consent to participate was obtained from all the patients.
A first prototype of the new supporting frame was initially used, characterized by the possibility of customizing both the length of the device and the circumference to achieve better adaptability to the amputated limb. The device also included an adjustable tube for further elongation of the device according to the size of the patient and a rocker foot adjustable for varus/valgus axes of the foot. Good aesthetics and good hygiene were also researched (Figure 1). Different prototypes were then built, improving material, including the one with an ischial support for patients with short residual limb or difficulty in limb loading. The supporting frame was used together with a pneumatic commercial bag (Ortho Euro, UK). The pneumatic bag was inserted into the supporting rigid frame and pumped up by the average of 60 to 70 mm Hg or within the patients' tolerance so that the bag does not move within the supporting frame while standing and walking.
Before amputation, patients received preoperative education in the rehabilitation ward to learn respiratory exercises and use of crutches. After amputation, they started a customized rehabilitation intervention consisting of sitting, mobilization of the residual limb, respiratory exercises, and exercise for the sound limb.
The fourth day after amputation, after the removal of drainage tube, patients were transferred to the rehabilitation unit where they continue rehabilitation intervention for pain management also with specific mirror therapy, preventing muscular shortening, maintaining joint range of motion while monitoring pain, strengthening residual limb muscles and contralateral muscles, recovering trunk posture control, standing and walking ability with and without the supporting device, improving neuromuscular control, and proprioception during walking.
Specifically, the training with the original device consisted of a first period of standing in between parallel bars wearing the device. Patients were asked to perform exercises such as moving the foot center of pressure on sagittal and frontal plane with bath scales under the operated limb to check the load applied, simulating the initiation of gait, and afterward walk in parallel bars with reduced loading on the amputated limb. As the patients became confident with the use of the device, the use of a walker or forearm crutches was introduced.
The procedure, first introduced by Borghi et al.18 for residual limb pain, is routinely used at our institute. It consists of the positioning of an intranerve catheter placed intraoperatively by the surgeon in the sciatic nerve on the amputated limb for continuous infusion of local anesthetic (ropivacaine 0.5% at 5 mL/h) utilizing an elastic pump. The amount of local anesthetic delivered is daily modified according to the reported patients' pain. The catheter is maintained in site at least 4 weeks after surgery. When necessary, a rescue therapy with opioid or nonopioid analgesics is associated.
Regardless of the level of amputation, the patients had, on average, pain with a mean visual analog scale score of less than 3 during admission, which improved at T2 (Table 2).
CLINICAL AND FUNCTIONAL EVALUATION
The surgical wound was regularly treated and covered with gauze to protect it from the pressure applied via the pneumatic device during exercise. Elastic bandage or a silicone liner was applied to the residual limb. Residual limb skin disepithelization around the wound was present at admission in two patients and resolved in 10 days.
The ROM of the joint proximal to the amputation level was generally constant through follow-up. All the patients showed improvement in 10-m walking time between T1 and T2. All the patients showed improvement in Musculoskeletal Tumor Society (MSTS) score between T1 and T2. At T2, the mean prosthesis evaluation questionnaire (PEQ) score of the patients after transfemoral amputation was 5.5 (range, 1.8–9.3) and that of the patients after transtibial amputation was 7.3 (range, 3.2–8.8), comparable but with a greater range with the value for persons with amputations (median, 6.6; range, 4.9–8.1; n = 123) at a median of 38 months after amputation.19 The 36-item Short Form Health Survey that evaluated health-related QOL at T2 indicated that, compared with the normal Italian population,20 the score of bodily pain in the patients was comparable with the reference value, whereas scores of general health perceptions, social role functioning, mental health, physical functioning, physical role functioning, and emotional role functioning were apparently worse (Table 3).
This feasibility study showed that temporary application of an original adjustable supporting frame for pneumatic bag as part of the rehabilitation program for patients after lower-limb amputation was beneficial without contraindication and adverse effects even when we applied it few days after amputation. Although different types of pneumatic aids for early recovery of walking are currently in use and demonstrated their effective role, the device here presented overcomes some limitations of the available aids owing to its greater adjustability for patients. The best fitting with the patient measures reduces problems related to possible discomfort, thus enhancing the rehabilitation process. In the present study, some clinical items (pain, wound condition, MSTS, etc.) were registered to evaluate possible negative impact of the device. Actually, no wound problems were encountered, no worsening of pain was registered with the use of the pneumatic device, and clinical and functional evaluation showed a good functional performance. All the patients were extremely satisfied with walking with the temporary device. No patients refused to use the device after application, and most of the patients, especially younger ones, asked if they could wear the device longer during the day and, possibly at home, while waiting for their temporary prosthesis. The early postsurgical use of the pneumatic device allowed gaining a very good functional outcome at PEQ with the temporary nonpneumatic prosthesis in a midterm follow-up and a satisfying QOL.
In conclusion, this technical note, despite the smaller number of the patients recruited and the consequent qualitative analysis of data, reports the safe use of the original supporting frame for pneumatic bag for patients after amputation for oncologic pathology allowing a rapid recovery of walking independence.
1. Mei J, Zhu XZ, Wang ZY, et al. Functional outcomes and quality of life in patients with osteosarcoma treated with amputation versus limb-salvage surgery: a systematic review and meta-analysis. Arch Orthop Trauma Surg
2. Harris IE, Leff AR, Gitelis S, et al. Function after amputation, arthrodesis, or arthroplasty for tumors about the knee. J Bone Joint Surg Am
3. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil
4. Pollack CV Jr, Kerstein MD. Prevention of post-operative complications in the lower-extremity amputee. J Cardiovasc Surg (Torino)
5. Condie E, Jones D, Treweek S, et al. A one-year national survey of patients having a lower limb amputation. Physiotherapy
6. Redhead RG. The early rehabilitation of lower limb amputees using a pneumatic walking aid. Prosthet Orthot Int
7. de Noordhout BM, Pirnay L, de Brogniez A. Early fitting of artificial limbs to amputated lower limbs. Acta Chir Belg
8. Little JM. A pneumatic weight-bearing temporary prosthesis for below-knee amputees. Lancet
9. Dickstein R, Pillar T, Mannheim M. The pneumatic post-amputation mobility aid in geriatric rehabilitation. Scand J Rehabil Med
10. Initial and interlimb prosthesis. Prosthetics, Lower Extremity
. Ottobock: Duderstadt, Germany; 2013.
11. Scott H, Condie ME, Treweek SP, et al. An evaluation of the Amputee Mobility Aid (AMA) early walking aid. Prosthet Orthot Int
12. Kerstein MD. Utilization of an air splint after below-knee amputation. Am J Phys Med
13. Sher MH. The air splint: n alternative to the immediate postoperative prosthesis. Arch Surg
14. Bonner FJ Jr, Green RF. Pneumatic Airleg prosthesis: report of 200 cases. Arch Phys Med Rehabil
15. Rausch RW, Khalili AA. Air splint in preprosthetic rehabilitation of lower extremity amputated limbs: a clinical report. Phys Ther
16. Palsule S, Desai O. Early post-operative rehabilitation with a pneumatic weight-bearing temporary prosthesis. Ind J Occup Ther
17. Mazari FA, Mockford K, Barnett C, et al. Hull early walking aid for rehabilitation of transtibial amputees—randomized controlled trial (HEART). J Vasc Surg
18. Borghi B, D'Addabbo M, White PF, et al. The use of prolonged peripheral neural blockade after lower extremity amputation: the effect on symptoms associated with phantom limb syndrome. Anesth Analg
19. Franchignoni F, Giordano A, Ferriero G, et al. Measuring mobility in people with lower limb amputation: Rasch analysis of the mobility section of the prosthesis evaluation questionnaire. J Rehabil Med
20. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol