Prosthetic interventions for people with transtibial amputation: Systematic review and meta-analysis of high-quality prospective literature and systematic reviews.

INTRODUCTION In the United States alone, approximately 185,000 amputations occur annually [1], contributing to an estimated population of 1.6 million persons living with limb loss [2-3]. Of these, approximately 1.3 million (86%) have amputation of the lower limb. Twenty-eight percent of people with lower-limb amputation, slightly more than 378,000 individuals, have a transtibial amputation (TTA) [2-3]. Approximately 72 percent of TTAs are attributable to vascular disease. Of those remaining, 7 percent of TTAs are of traumatic etiology [2-3]. There is a higher incidence and prevalence of dysvascular-related amputation associated with advancing age [2-4]. Adding to the subpopulation of people with traumatic amputation within the past 10 yr has been the number of persons who have experienced amputation(s) related to U.S. military service in association with Operations Iraqi Freedom, Enduring Freedom, and New Dawn [5]. Considerable attention has been directed to amputation as a result of the conflicts in the Middle East, which have stimulated technological advancement in prosthetic rehabilitation [6]. While the increase in amputations within the military sector is substantial, from a societal perspective, the population of those with military-associated amputation(s) is comparatively small. There have been 1,221 persons engaged in military service who have experienced 1,631 amputations from 2001 to 2011 [5]. Of these, 683 amputations (or 41.9%) were at the transtibial level and 366 people experienced multiple amputations. Many of these included a TTA [5]. Those individuals who have lost a limb (or limbs) in military service are commonly within the third decade of life and will require a much longer duration of care over their remaining lifetime compared with those who lose limbs to vascular disease, which is more common after the fourth or fifth decade of life [5]. It is likely that those who lose a limb in military service have higher functional ambulation standards that will challenge the healthcare system accustomed to providing care for persons who have lost limbs to vascular disease. It is known that persons with TTA develop secondary conditions related to overuse of the sound limb, prosthetic malalignment of components relative to interface, and other factors. These conditions may include degenerative joint disease, osteopenia, postural issues, low back pain, skin issues, and others [7-8]. Nevertheless, many individuals with TTA lead functional lifestyles [9], at times participating in sports and athletic pursuits [10]. Incorporation of a transtibial prosthesis is routinely part of the rehabilitation and reintegration plan [11]. Typical prostheses ideally include a comfortable, optimally aligned socket interface, pylon, and foot. Prior to providing this prosthesis, some form of postamputation care is common. Problematically, there is no consensus to guide any of the aforementioned prosthetic elements. The common inclusion of a prosthesis is, however, a considerable healthcare expense over the lifetime for the person with TTA. For example, Blough et al. estimated that prosthetic costs over the lifetime for an individual with unilateral lower-limb amputation could range from $0.5 million to $1.8 million, depending on the number of prostheses in service at a given time, the type of prostheses, and other factors [12]. Collectively, total care for a person with amputation of dysvascular etiology had an estimated U.S. societal cost of $4.3 billion in 1996, and Medicare reimbursed $655 million worth of lower-limb prosthetic services in 2009 [13-14]. Given the remarkable costs associated with hospital and facility fees, amputation rehabilitation, and prosthetic provision, it is problematic that so much of the associated literature is noncommittal, inconclusive, and ultimately unable to guide clinical practice or reimbursement. For example, prominent reviews on the subjects of foot prescription [15] and postoperative management [16] conclude by indicating that no clinical recommendations can ultimately be made given a lack of evidence or of high-quality evidence. …