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Standards Of Care

Because agreement about the protocol for the various strategies was not possible, the participants felt that the standards of care should be based on the various goals required to achieve appropriate rehabilitation. The minimum standards of care identified by the conference committee were discussed; the essential components of postoperative care were identified as:

  • Team involvement

  • Time frame of surgery and recovery

  • Wound healing

  • Amputation-specific goals

  • "Whole person" goals

  • Education and empowerment of the amputee and family

TEAM INVOLVEMENT

As delivery of health care has evolved, it is more difficult to have the whole team together at the same time. The reality is that there is less time when the individual providers can meet with the patient "as a group" and less time for the individual providers to communicate directly. However, the team approach is still needed to optimize recovery from limb loss, perhaps now more than ever. As McKeever 1 stated in 1972, the results in any series of amputations are directly related to the skill and enthusiasm of the people involved in the program. The team approach to lower limb amputation surgery remains vital. Team members may be seeing the same patient at different locations in the same day, making direct communication more of a challenge.

This "team without walls" demands increased effort and attentiveness to continue to work toward the common goal of maximum recovery and rehabilitation after limb loss. It demands increased efforts for the various providers to communicate on behalf of the patient.

The team should be flexible in that different people share the leadership and service responsibilities throughout the 12- to 18-month time frame that typically defines the postoperative period. Each clinician has an obligation to first educate and empower the amputees and/or their advocates and then allow them to take control and responsibility. This acceptance of control and responsibility happens at different points along the way for different individuals.

Members of the team may include patient, family, surgeon, physiatrist, therapist, prosthetist, nurse, social worker, psychologist, peer support, and case manager, and all have important roles and responsibilities in optimizing postoperative amputee rehabilitation.

First and foremost, the members must always "act like a team." No single health care provider has all the answers, and everyone has specific skills and roles to assist in the pre- and postoperative process. Keeping a positive and motivating approach when differences of opinion occur (as they will) and keeping an open mind are critical for appropriate care. All team members can learn from each other and have an obligation to educate the patient and the other team members.

All team members have a responsibility to the ultimate idealized outcome. All providers have a responsibility to envision the best possible outcome and help to assure that medical care, prosthetic fabrication and fitting, training and therapy, navigation of the funding process, and social reintegration occur.

It is essential that the team work together, support or discuss each member's treatment recommendations, and communicate directly when a disagreement exists. Communicating through the patient should be avoided at all costs . In addition, destructive talk and finger pointing have a huge negative impact on patient trust, outlook and, ultimately, on the expected outcomes.

TIME FRAME OF SURGERY AND RECOVERY

Understanding the time frame of recovery from lower limb amputation is essential to the design and implementation of any postoperative management strategy. Although today's health care system has placed an emphasis on speed, the committee agreed that placing an emphasis on shortening the time of healing and recovery following limb loss is not necessarily the wisest path . After amputation (regardless of the etiology), the postoperative recovery period (including activity recovery, reintegration, prosthetic management, and training) typically is 12 to 18 months and simply cannot be rushed . 2 Some on this committee felt that setting fast-paced and often unrealistic goals can lead to a sense of failure in an individual who is actually progressing normally. The postoperative year-long continuum does not separate easily into "stages"; however, for the purposes of this document we attempt to define stages to facilitate discussion of how the goals evolve throughout the process. The five stages we identified are:

  1. Preoperative stage . The preoperative stage typically starts with the very difficult decision of whether to amputate. This stage also includes an assessment of the vascular status and decisions on attempts to improve circulation. The diffi- cult process of level selection, preoperative education, emotional support, physical therapy and conditioning, nutritional support, and pain management also all occur in this stage of care.

  2. Acute hospital postoperative stage . The acute hospital postoperative stage is the time in the hospital after the amputation surgery. This hospital time typically ranges from 5 to 14 days.

  3. Immediate postacute hospital stage . In general, this stage begins with hospital discharge and extends 4, 6, or even 8 weeks after surgery. This is the time of recovery from surgery, a time of wound healing, and a time of early rehabilitation. Frequently, end points of this stage are characterized as the point of wound healing and the point of being ready for prosthetic fitting. However, it should be noted that healing of a residual limb is a continuous process, and the limb does not have a clear and decisive point of "being healed." Furthermore, prosthetic readiness is a transition point that is difficult to standardize and measure. Much of the current research comparing different postoperative management strategies attempts to use these two elusive end points with varying results.

  4. Intermediate recovery stage . This is the time of transition from a postoperative strategy to the first formal prosthetic device. Historically, this device was called the "preparatory" prosthesis, but with the use of higher technology earlier in the process, it is sometimes simply called the "first prosthesis." The term "preparatory" has traditionally been linked to very basic prosthetic styles and components. The committee felt that the historical interpretation of "preparatory prosthesis" is no longer adequate. It is during this stage that the most rapid changes in limb volume occur, due to the beginning of ambulation and prosthetic use. The immediate recovery period begins with the healing of the wound and usually extends 4 to 6 months from the healing date. Although difficult to define, this stage ends with the relative stabilization of the residual limb size, as defined by consistency of prosthetic fit for several months.

  5. Transition to stable stage . This period is defined as a period of relative limb stabilization after stage 4 when rapid limb volume changes occurred. Although limb volume changes are not as drastic as in this stage, the limb will continue to change to some degree, for a period of 12 to 18 months after initial healing. Historically, this stage was marked as a transition from the "preparatory" to the definitive prosthesis. Currently, with the use of higher technology and modular systems in stage 4, this transition is no longer defined by a change in the prosthesis, but rather a change from a rapidly changing limb to a slower maturation of the limb. The prosthesis will still require occasional adjustments, and visits to the prosthetist will remain relatively frequent until after the first year of prosthetic use. Modular systems are appropriate and encouraged to enhance ease of socket replacement in this stage. In this phase the patient should move toward social reintegration and higher functional training and development as well as becoming more empowered and independent from his or her health practitioner.

CHANGING CLINICAL CONCERNS DURING THE STAGES OF RECOVERY

The committee felt that during this 12- to 18-month continuum, the levels of clinical concern changed in their importance as the patient matures through the healing process. The changing clinical concerns are outlined in Table 1 . Each goal on the left side of the table is ranked in relative importance with regard to the level of clinical concern at each stage of rehabilitation. For example, the determination of amputation level is of concern at the preoperative stage. However, it is usually of little clinical concern after the surgery. Conversely, emotional care is of high clinical concern through most of the rehabilitation process, with slight drop off in the intermediate recovery stage and with a renewed concern at around 1 year after the amputation.

In addition, because of individual differences there may often be overlap in clinical concerns through various time periods. Although some patients may evolve to the last stage with one clinical concern they should not be expected to do so with all concerns.

Although progression through these phases is largely individual, the time needed to progress is reported consistently between 12 and 18 months. It is during this extended time that many individuals still have significant changes in limb volume that must be considered and managed. Social reintegration, life planning, and goal setting all progress during the period of 12 to 18 months. Finally, in the later portions of the process come the mastery of prosthetic use and a desired range of activities. For pediatric amputees, the stages of recovery and the clinical concerns are modified to take into account the developmental milestones of the growing child.

The fitting of the definitive prosthesis may certainly occur within this time period; however, limb stabilization must occur before definitive fitting. Volume must be stable so the device can be used for an extended period of time (2-5 years in adults and as long as 1 year in growing children). Defining limb stability is very difficult; for most patients the period of limb stabilization requires at least 6 months of prosthetic use.

Although the role of all team members is to assess, educate, and motivate the patient, the role of two particular members of the team, the physical therapist and the prosthetist, during this long period is often underestimated. Physical therapy treatment continues throughout this entire period with specific rehabilitation protocols designed to meet the specific needs of each amputee. Continual reevaluation and updating of the amputee's program is essential to ensure that each patient reaches his or her maximal activity level with a prosthesis. Although the patient must be an active participant in his or her rehabilitative care, the treatment guidelines and specific exercises are the therapist's responsibility and an integral component of the continuum of care for the first 12 to 18 months.

Initial prosthetic management after amputation requires strategies different from those used during the period after residual limb stabilization. During the initial time frame, the prosthetist is "chasing a moving target," as the residual limb changes dramatically in volume and shape. Therefore, the definitive prosthesis should not be prescribed or fit until the limb has begun to stabilize and the "moving target" has slowed considerably. Stabilization is difficult to define and needs to be further researched; however, when a patient has used a prosthesis full time for a period of at least 6 months and when the limb volume has stabilized to a point that socket fit remains relatively consistent for at least 2 to 3 weeks, a definitive prosthesis may be indicated. Additional studies need to be done to determine the appropriate intermediate techniques for edema reduction and to define limb stabilization. Little literature is available that attempts to define when adjustment of the current socket may meet the needs of the patient versus when socket replacement is required. Clearly, research is needed in this area. Finally, it should be noted that a patient may return to work during this process, not just at the end of the process.

WOUND HEALING

Many lower limb amputations do not heal ideally in a primary fashion, and it is common that small areas of the wound require secondary healing and a period of minor open wound care. Revision surgery is also frequently required. 3 Wound healing problems are most commonly related to the injury, disease, vascularity, tobacco use, and the nature of amputations themselves. Skin and wound problems are rarely "caused" by a single factor and for many individuals are not preventable. In actuality, it is uncommon for lower limb amputations to heal primarily with no wound issues.

It should be noted that healing of an amputated limb is a continuous process, and there is not a clear and decisive point of "completed healing." Therefore, "time to heal" is not a precise measure; however, documenting healing continues to be important for patient care and for research.

Determining healing time is prone to subjective interpretation of completion of epithelialization, interpretation of the small open areas, individual bias, timing of the return to clinic visits, and "research savvy" of the prosthetic and rehabilitation team. Thus, it is important that future studies clearly define how the "time to heal" has been determined for each particular study. "Time to heal" may always be difficult to standardize and to measure, and in reality cannot be determined accurately from simple retrospective review of a clinical chart. The conference group recommends that wound healing be documented as a type of wound healing for clinical and research purposes, as defined below.

CATEGORIES OF WOUND HEALING

Category I. Primary: heals without open areas, infection, or wound complications.

Category II. Secondary: small open areas that can be managed, and ultimately heal with dressing strategies and wound care. Additional surgery is not required. This can occasionally be the original plan with some portion of the amputation intentionally left open.

Category III. Requires minor surgical revision: skin and subcutaneous tissue (no muscle, no bone).

Category IV. Requires major surgical revision involving muscle or bone: but heals at initial amputation "level." For example, a midlength transtibial amputation that is revised and eventually heals at a shorter transtibial level.

Category V. Requires revision to a higher amputation level: for example, a transtibial amputation that must be revised to either a knee disarticulation or a transfemoral amputation.

WOUNDS AND WEIGHT-BEARING ACTIVITY

The presence of an open wound or the presence of sutures does not necessarily preclude weight bearing. In many circumstances, institution of (or continuation of) activity can be helpful in controlling edema and facilitating healing. This has been demonstrated in the literature since the early 1920s. 4 Good direct communication about healing issues and wounds among providers and education of the patient are vital. Repeated wound assessment and modification of the treatment plan as needed are important. Decisions should be made based on the progression of the particular wound, the lack of progression, or the worsening wound appearance.

Although initial instincts are to avoid prosthetic use and weight bearing whenever there is a wound or skin problem, this may not be appropriate in some cases. While a treating physician must examine the wound and the prosthetist must examine the device for evidence of device-specific pressure points (and modify the device if any are found), the literature actually supports weight bearing and continued activity in certain situations to enhance wound healing. 4,5

AMPUTATION-SPECIFIC GOALS

During lengthy discussion, it became evident that some of the standards of care were specific to the amputation itself, and others were more concerned with the general health and well-being of the patient. The following are areas of concern specific to the amputation itself.

  1. Prevention of contractures is necessary at both the hip and the knee. Although several passive strategies, such as knee immobilizers and rigid dressings, attempt to address the goal of knee flexion contracture prevention in the transtibial amputee, literature is unavailable to support any one strategy. Passive strategies to prevent hip flexion contractures in either the transtibial or transfemoral amputee have yet to be proposed. Active strategies to prevent contractures are well documented for the transtibial or transfemoral amputee and include bed positioning, prone activities, various stretching techniques and knee and hip joint mobilization by a physical therapist.

  2. Reduction of postoperative edema through the use of compressive therapies is important after any amputation. All postoperative strategies may be of some value in edema reduction. It is clear from the literature that soft compressive dressings are used in many centers as a primary means of treatment. Therefore, proper wrapping techniques must be taught to the staff and to the patient and caregivers to reduce complications.

  3. Bed mobility, transfers in and out of bed and on and off the toilet, and other activities of daily living must be taught early in the postamputation period to promote and encourage independence, increase strength, and reduce the fear of falling. Physical therapy and occupational therapy are essential to these processes. Often pain (or fear of pain) limits bed mobility, so any strategy that provides limb protection may improve mobility. The addition of a pylon and foot may make bed mobility slightly more difficult because of the extra length, weight, and bulk, particularly if knee flexion is not possible.

  4. Pain management of acute perioperative pain, as well as chronic pain issues, must be addressed. Anecdotally, there appears to be some relationship between pain and contracture; however, this is not supported in the literature. Pain must be controlled throughout the perioperative period to facilitate mobility and eventual prosthetic use. Careful evaluation of pain, taking into consideration the 12- to 18-month period outlined above, will assist in determining the appropriate treatment modality. It may be important to vary the pain management strategies, such as medicine or manual desensitization based on the time from surgery, the type of postoperative dressing, and the cause of amputation. Desensitization is believed to reduce pain in the residual limb and may help the amputee adjust to his or her new body image that now includes limb loss. Although widely described, the appropriate literature is lacking with regard to the relationship between any one approach and pain control. Controlled studies are needed in this area.

  5. Protection of the amputated limb from outside trauma is important to reduce the potential of complications and delayed wound healing and to encourage mobility. Rigid dressing strategies (either custom or prefabricated) clearly provide better limb protection than do soft dressings. Elastomeric liner systems may intuitively provide some protection; however, comparative research trials are lacking.

  6. Fall prevention is an essential part of amputation rehabilitation. Complications secondary to falls may result in significantly increased healing time, additional surgical intervention, other injuries, and increased hospitalization. There is some evidence that the application of a strategy that incorporates a pylon and foot system reduces the number of falls. 6 Other strategies, such as "limb loss reminders" (ie, placing a chair on the side of the bed where the patient gets up to "remind" him or her to be careful), may reduce the incidence of complications from falls, but additional study is needed. Therapeutic interventions such as balance and strength training may help reduce the number of falls.

  7. Emotional care is essential from the day the decision to amputate is made. Treatment must be highly individualized and does not appear to be related to the postoperative strategy. Much of the literature touts the emotional benefit of one strategy over another, but there has been no scientific evidence supporting these claims. Documented helpful options include supportive encouragement, educational literature, psychological counseling, peer counseling, amputee support groups, and chaplainry. The risk of depression in amputees is high; when necessary, pharmacologic intervention and/or psychiatric referral should be considered. Although the conference attendees felt that emotional response could not be correlated with the postoperative limb management strategy used, there is a need for research in this area.

  8. Promotion of residual limb activity (such as desensitization, muscle contraction, and endurance development) is important and, although it may be instituted at various times based on postoperative strategy, cause of amputation, and surgical procedures, the group believes that the earlier the intervention, the better. Exercise to improve gluteus (medius and maximus) and quadriceps strength may start as early as day 1, but exercises to promote muscle action within the residual limb should begin with pain tolerance, and depend on the specific surgical procedure and the healing response. Muscle contraction within the residual limb may help with pain control, muscle re-education, improvement of muscle mass, edema control, and improved kinesthetic feedback. Again, research is lacking in this area. The timing for the beginning of muscle activity within the residual limb needs to be further evaluated. No evidence exists about whether one postoperative strategy could inhibit or enhance residual limb musculature.

  9. Trunk stability should be established as early as possible through core strengthening of the pelvic, trunk, and shoulder girdle musculature. Trunk stability will assist with mobility activities and provide the foundation for prosthetic control, sitting posture, and standing posture. Trunk stability can also reduce the stresses to the spine that can lead to low back pain and body motor control and stability problems. This prosthetic and preprosthetic therapy may improve body posture and readiness for gait training. In addition, it may decrease the commonly seen gait deviations and provide for better body awareness when ambulating with the prosthesis. Improved motor control should decrease the energy expenditure of walking with a prosthesis.

  10. Ambulation may be described as nonpedal (wheelchair ambulation), unipedal (on remaining limb with assistive device), or bipedal (using a prosthetic pylon), with or without assistive devices. Improvements in strength, mobility, balance, and endurance have been shown to decrease the potential for comorbidities, such as pulmonary embolism, deep vein thrombosis, myocardial infarction, and more.

  11. Accommodating limb volume changes during the intermediate recovery stage is critical to comfortable prosthetic use. During this stage, the limb volume is fluctuating wildly and may be difficult to manage. Predominately, control of limb volume changes during this stage is a function of the preparatory prosthesis, but strategies should be used that incorporate volume control. Strategies include the use of liners, socks, pads, adjustable sockets, temporary sockets, or ambulatory check sockets. These techniques may assist with maintaining appropriate fit and function when the patient is wearing a prosthesis. When the patient is not wearing a prosthesis, wrapping and/or compression are critical to help control limb volume changes.

  12. Distal end loading, desensitization, and residual limb weight bearing may assist with pain control, tolerance of a prosthesis, and reduction of adhesions. This may begin with towel pulling on the distal end of the residual limb, or may occur with strategies that are rigid and allow for distribution of pressure over the entire residual limb.

"WHOLE PERSON" GOALS

The committee identified six "whole person" goals of care for anyone undergoing lower limb amputation. (These goals are not directly related to the surgical amputation but are intended to prevent comorbidity and to improve overall health and mobility.)

  1. Musculoskeletal reconditioning and cardiopulmonary training

  2. Contralateral lower limb preservation

  3. Emotional care related to concepts of loss, mourning, and the need for peer support and education

  4. Minimization of systemic complications: myocardial infarction, joint contractures, deep venous thrombosis, pneumonia, and decubitus ulcerations

  5. Social reintegration

  6. Setting of realistic patient expectations and functional outcome goals

Although all of these are extremely important, the committee feels the need to highlight and expand upon the areas of emotional care, social reintegration, and setting realistic patient expectations and functional outcome goals.

EDUCATION AND EMPOWERMENT OF THE AMPUTEE AND FAMILY

"...Support enables patients to express their emotional reactions and gain a sense of comfort and security... Outcomes of such psycho-educational sessions include lowering distress ... strengthening the immune system, controlling pain ... raising self-esteem and optimism, and resolving the many problems of daily adjustment." 7

Emotional support and education must be incorporated with prosthetic fitting and general rehabilitation. The enthusiasm and willingness of the care providers to provide psychosocial support to the patient increases the patient's education and understanding of the recovery process. Education leads to empowerment, and the "patient" then becomes a "participant" in his or her own care, taking responsibility for positive outcomes. Amputation necessitates an individual process of recovery, and each person approaches the situation differently. With educational support from the team and community resources such as peer education, these individuals will be more able to become participants during their recovery process.

IMPROVED UNDERSTANDING OF SURGICAL TREATMENT

From the first possible moment, educating patients about the need for and type of surgery will help them understand their medical situation. Understanding what is being done helps them realize the efforts of others and may provide a stronger sense of trust in the team. Discussion with the patient and family members about surgery should include types of anesthesia, surgical techniques, the possibility of phantom limb sensation/pain, and pain control. In skeletally immature patients, the possibilities of bony overgrowth distally or growth plate damage because of trauma or ischemia should be mentioned, along with the possible need for surgical treatment for these conditions.

IMPROVED UNDERSTANDING OF THE TIME FRAME OF RECOVERY

Understanding the actual time of surgical recovery and the processes involved in recovery, including the sequence of events with respect to time for healing, is essential when the team (which includes the patient) sets the rehabilitation goals. It helps the patient and family achieve realistic expectations. Discussing realistic time frames helps avoid unrealistic goals and the potential for disappointment and frustration, which could otherwise result in noncompliance. It is important to remind the caregivers and the amputee that each person progresses at his or her own pace and although the path is individual, the usual expectation is for a 12- to 18-month period of adjustment.

IMPROVED UNDERSTANDING OF THE EMOTIONAL ADAPTATION ASSOCIATED WITH LIMB LOSS

The team should remember that emotional responses may affect postamputation outcomes. As in any life-altering situation, individual patients respond differently to amputation. Recognizing that each person adapts to his or her new life uniquely will help promote a plan of recovery directed to the specific person. Emotional adaptation may be greatly affected by culture and family history, religious preference, age, education, social acceptance, financial background, and social support. The consensus conference highlighted that more research into the effects of emotional adaptation on outcomes is needed.

IMPROVED UNDERSTANDING OF PROSTHETIC PLAN, FABRICATION, FITTING, ALIGNMENT, AND TRAINING

Education about prosthetics and prosthetic services is essential in the recovery plan for amputees. It is important to give the patient information about the role of the prosthetist, how to choose a prosthetist, what prosthetics is, and how a prosthesis is funded. Through the team approach, the sharing of information and support from the various disciplines will enhance the patients' perspective of the future. It is important to recognize that the use of a prosthesis is not a determinant of full recovery. Some amputees may never reach a level of comfort emotionally or physically with prosthetic wear. Individuals may choose not to use a prosthetic limb but may use another form of adaptive equipment for mobility (such as crutches, walker, wheelchair, or power scooter) in achieving their rehabilitation goals.

PEER SUPPORT, CONSUMER GROUPS

Today, there are many useful resources for peer support and consumer education. Peer support provides an opportunity for amputees to relate to one another and may be an emotional outlet. Peer-to-peer support can provide information and education that may not be achieved in any other team relationship. The committee agreed that peer visitation, amputee support groups, and consumer awareness are useful resources for amputees, families, and care providers.

NAVIGATE THROUGH THE MARKETING, HYPE, AND REALITIES

It is important to educate and re-educate amputees on the realities of prosthetics, function, and "quick fix" products. Although componentry can facilitate and improve the ability to perform a particular activity, components alone do not dictate the ability to engage in those activities. The process of determining and utilizing specific components (ie, type of foot) varies among prosthetists and clinicians. It is important to remember that several types of components from different manufacturers may be appropriate for the individual, and no one combination is ideal for all situations.

Correspondence to: Gary Berke, MS, CP, 801 Brewster Avenue, Suite 270, Redwood City, CA 94063; e-mail: gberke@pacbell.net .


References:

  1. McKeever FM. Editorial. Am J Surg 1972;124:133.
  2. Smith DG, Horn P, Malchow D, et al. Prosthetic history, prosthetic charges, and functional outcome of the isolated, traumatic below-knee amputee. J Trauma 1995;38:44-47.
  3. Pinzur MS, Gottshalk F, Smith DG, et al. Functional outcome of below-knee amputation in peripheral vascular insufficiency: a multicenter review. Clin Orthop 1993;286:247-249.
  4. Wilson PD. Early weight-bearing in the treatment of amputations of the lower limbs. J Bone Joint Surg Am 1922;4(2):224-247.
  5. Zettl JG, Burgess EM, Romano FL. The interface in the immediate postsurgical prosthesis. Bull Prosthet Res 1969;8:10-12.
  6. Schon LC, Short KW, Soupiou O, et al. Benefits of early prosthetic management of transtibial amputees: a prospective clinical study of a prefabricated prosthesis. Foot Ankle Int 2002;23: 509-514.
  7. Sperber-Ritchie B. Resilience in survivors of traumatic limb loss, "The impact of early intervention and education after a traumatic event." Disabil Stud Q 2003;23(2):36-44.