Fig. 1 Intraoperative photograph of the lower limb of a patient who sustained severe injury from an explosion (A). The soft tissue surrounding the midfoot was severely compromised and ultimately nonviable, precluding salvage. Large soft-tissue and skin defects over the mid- and proximal tibia prevented a primary transtibial amputation. To preserve optimal length of the residual limb and provide stable soft-tissue coverage, a Syme disarticulation was planned. The distal fish-mouth incision with removal of the talus and calcaneus has been performed at this stage. Preoperative radiographic views of the tibia (B) and the forefoot (C) show segmental comminution and multiple fractures and dislocations.
Reproduced from Atlas of Amputations and Limb Deficiencies, Ed.4, Vol.2. P. 474. Rosemont, Il: American Academy of Orthopaedic Surgeons 2016.

AAOS Now

Published 12/31/2019
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Terry Stanton

New CPG Guides Decision Making for Limb Salvage or Amputation

The clinical practice guideline (CPG) for Limb Salvage or Early Amputation, approved by the AAOS Board of Directors in December 2019, advises that initial management decisions for a severely injured lower extremity are dependent on both the assessment of injury itself and the overall health of the patient. If it is determined that an attempt at limb salvage would increase the risk of mortality in the acute setting, amputation is the treatment of choice.

In the introduction to the guideline, the workgroup noted, “Advances in the treatment of severe high-energy lower-extremity trauma (HELET) have significantly improved the surgeon’s ability to enter and progress patients through a successful limb-salvage treatment pathway. The selection of the appropriate patient and/or injury burden for limb-salvage efforts, however, remains controversial.”

The guideline (available through the OrthoGuidelines app or at orthoguidelines.org) is the product of a collaborative effort of the AAOS Committee on Evidence-based Quality and Value Committee (EBQV) and the Major Extremity Trauma and Rehabilitation Consortium (METRC), an initiative funded by the Department of Defense and the Orthopaedic Extremity Trauma Research Program. The group noted, “Recent research from military combat casualties has further challenged our concept of best patient selection for limb salvage.” In the 2013 METALS study of 324 patients with complex lower-extremity combat injuries, amputation patients had better functional outcome scores compared to reconstruction patients.

With that background information, the guideline seeks “to improve treatment selection for patients with severe lower-limb trauma based on the current best evidence.”

“The development of new CPGs and appropriate use criteria stems from a the first-ever grant awarded to AAOS from the Department of Defense,” said Kevin G. Shea, MD, chair of the AAOS EBQV. “The trauma-related injury topics identified through the grant were areas in which significant variation in orthopaedic emergent care existed. We sought to provide physicians with a measure of when, how, and for whom medical and surgical procedures should be used when dealing with traumatic extremity injuries to better optimize patient care—whether civilian traumatic events such as motor vehicle accidents or military scenarios.”

For the purpose of this guideline, the decision-making opportunity is defined in two time points: time zero and time 1+. Time zero is the initial surgical contact, in close proximity to the time of injury. Time 1+ represents all future evaluations that provide information that further supports or alters the initial treatment decision.

A ‘nuanced discussion’

Benjamin J. Miller, MD, MS, FAAOS, the oversight chair for the CPG on behalf of the EBQV, said that the group agreed that the timing of the recommendations in regard to the short- and long-term goals required clarification. “The decision for limb salvage or amputation was agreed to be specifically at the time of the initial surgical intervention—a time when the focus is on resuscitation and stabilization of the acute injury,” he said. “The subsequent decision of limb salvage requires a nuanced discussion, dependent on many factors and requiring an informed conversation with the patient regarding the expectations of function and potential adverse events (AEs). In addition, this CPG applies only to lower-extremity trauma distal to the femur and does not address more proximal injuries.”

Of the 11 recommendations in the CPG, six are supported by evidence categorized as moderate (evidence from two or more moderate-quality studies with consistent findings or evidence from a single high-quality study), and one is backed by strong evidence (from two or more high-quality studies with consistent findings for recommending for or against the intervention).

The strong recommendation advises: “Clinicians should screen all patients with [HELET] for psychosocial risk factors (e.g., depression, post-traumatic stress disorder [PTSD], anxiety, low self-efficacy, poor social support) affecting patient outcomes.”

Dr. Miller said that this guidance is “a clear recommendation that psychosocial factors strongly influence patient outcomes and that screening for depression, PTSD, anxiety, and diminished social support should be routine. This is important, as it can be overlooked as the healthcare team focuses on the more tangible goal of physiologic injury management.”

The guideline document notes that a particular challenge in constructing the CPG was the fact that the topic does not lend itself to prospective, randomized clinical trials; as such, strong evidence to guide treatment recommendations was often lacking. In the future, registry outcome data could greatly impact the ability to make recommendations based on outcomes.

“Retrospective and prospective longitudinal studies are inherently impacted by both surgeon and patient treatment decision bias,” the workgroup wrote. Therefore, identifying the correct patient who would benefit from early amputation is challenging. The only absolute indication for an amputation at time zero is the inability to restore or maintain limb perfusion. Patient autonomy and perceptions about the perceived benefit of limb salvage or the stigma of amputation make the decision even more complex. “In the era of shared decision-making, patients with severe injuries [who] are expected to have dismal outcomes under limb salvage can and do refuse amputation despite appropriate counseling.”

In the burden-of-injury section of the CPG, moderate recommendations advise, “The physician team should prioritize patient survival in the limb reconstruction [versus] amputation decision. Limb-specific damage-control (i.e., temporizing) measures or immediate amputation should be considered when further attempts at definitive salvage will increase risk of mortality.” Physicians also “should consider the cumulative injury burden (soft tissue, vascular, nerve, bone, joint) of the limb when counseling patients on anticipated outcomes of and making recommendations on when to pursue limb salvage or amputation treatment.”

Addressing specific factors in clinical decision-making, a recommendation concerning ischemia advises that limited evidence suggests “that neither hard signs of vascular injury nor duration of limb ischemia are absolute factors in the decision for limb salvage [versus] amputation. However, the panel recognizes that prolonged ischemia is detrimental, and the interval to reperfusion should be kept to a practical minimum. The duration of lower-extremity ischemia is directly correlated with [AEs].”

Fig. 1 Intraoperative photograph of the lower limb of a patient who sustained severe injury from an explosion (A). The soft tissue surrounding the midfoot was severely compromised and ultimately nonviable, precluding salvage. Large soft-tissue and skin defects over the mid- and proximal tibia prevented a primary transtibial amputation. To preserve optimal length of the residual limb and provide stable soft-tissue coverage, a Syme disarticulation was planned. The distal fish-mouth incision with removal of the talus and calcaneus has been performed at this stage. Preoperative radiographic views of the tibia (B) and the forefoot (C) show segmental comminution and multiple fractures and dislocations.
Reproduced from Atlas of Amputations and Limb Deficiencies, Ed.4, Vol.2. P. 474. Rosemont, Il: American Academy of Orthopaedic Surgeons 2016.
Fig. 1 Intraoperative photograph of the lower limb of a patient who sustained severe injury from an explosion (A). The soft tissue surrounding the midfoot was severely compromised and ultimately nonviable, precluding salvage. Large soft-tissue and skin defects over the mid- and proximal tibia prevented a primary transtibial amputation. To preserve optimal length of the residual limb and provide stable soft-tissue coverage, a Syme disarticulation was planned. The distal fish-mouth incision with removal of the talus and calcaneus has been performed at this stage. Preoperative radiographic views of the tibia (B) and the forefoot (C) show segmental comminution and multiple fractures and dislocations.
Reproduced from Atlas of Amputations and Limb Deficiencies, Ed.4, Vol.2. P. 474. Rosemont, Il: American Academy of Orthopaedic Surgeons 2016.
Fig. 1 Intraoperative photograph of the lower limb of a patient who sustained severe injury from an explosion (A). The soft tissue surrounding the midfoot was severely compromised and ultimately nonviable, precluding salvage. Large soft-tissue and skin defects over the mid- and proximal tibia prevented a primary transtibial amputation. To preserve optimal length of the residual limb and provide stable soft-tissue coverage, a Syme disarticulation was planned. The distal fish-mouth incision with removal of the talus and calcaneus has been performed at this stage. Preoperative radiographic views of the tibia (B) and the forefoot (C) show segmental comminution and multiple fractures and dislocations.
Reproduced from Atlas of Amputations and Limb Deficiencies, Ed.4, Vol.2. P. 474. Rosemont, Il: American Academy of Orthopaedic Surgeons 2016.
Fig. 2 A clinical scenario for which the appropriate use criteria on Limb Salvage or Early Amputation recommends early amputation

On the topic of smoking, a recommendation counsels that a patient’s smoking/nicotine use should not be used as a critical decision-making factor at time zero, although it also advises, “Physicians should recommend nicotine education/cessation (abstinence of nicotine) for all patients with [HELET], as there is moderate evidence to suggest that smoking/nicotine use has a detrimental effect on outcomes for both amputation and limb salvage.”

In regard to nerve damage, a recommendation advises, “Limited evidence suggests plantar sensation or an observed nerve transection is not a factor in the decision for limb salvage [versus] amputation.” Dr. Miller commented, “Historically, it has been felt that loss of plantar sensation of the foot, manifested by loss of the tibial nerve, perhaps was an absolute contraindication for limb salvage. However, the literature review and group conversations yielded agreement that this factor alone did not adversely affect outcomes of limb salvage and should not drive the decision for amputation at the initial operative procedure.”

On the recommendation concerning rehabilitation, Dr. Miller said, “A structured rehabilitation program, including physical therapy, occupational therapy, and behavioral health interventions, can improve both the physical and psychosocial results in patients with high-energy, lower-extremity injuries. The literature, and conclusions of the expert panel, demonstrated clear agreement that focusing on a program to increase mobility, regardless of the pathway chosen for final limb management, has substantial benefit and limited risk.”

Perspectives aligned

The collaboration between the AAOS EBQV and METRC “was a fruitful example of collaboration between several stakeholders working to achieve a common goal,” Dr. Miller said. “The assembled workgroup informed the discussion with many different perspectives on patient management, both initially and long-term, and represented a comprehensive cross-section of the important issues and goals in the care of patients with a lower-extremity traumatic injury.”

The CPG may assist clinicians in two ways, he said: “First, it specifies the factors that should weigh heavily on an initial decision to amputate—survival of the patient and resuscitative efforts—and findings that should inform subsequent discussion with the patient but not necessitate an acute amputation (vascular or nerve status, injury scores, and smoking status). Second, it defines the important criteria that may make limb salvage more or less advisable in the short term. These characteristics will help healthcare professionals have an informed and data-driven conversation with patients as to the eventual expectations of function and potential complications with either pathway.”

Terry Stanton is the senior science writer for AAOS Now. He can be reached at tstanton@aaos.org.

Reference

  1. Doukas WC, Hayda RA, Frisch HM et al: The Military Extremity Trauma Amputation/Limb Salvage (METALS) study: outcomes of amputation versus limb salvage following major lower-extremity trauma. J Bone Joint Surg Am 2013;95:138-45.

Tool offers clinical guidance based on CPG

Along with the clinical practice guideline (CPG) on Limb Salvage or Early Amputation, the AAOS Board of Directors approved a new set of appropriate use criteria (AUC) to provide clinicians with guidance on diagnosis and management decisions for patients with severe lower-extremity trauma.

AUC are online tools (available through the OrthoGuidelines app or at orthoguidelines.org) that provide clinicians with algorithms on how to optimally treat orthopaedic injuries or conditions, including hypothetical scenarios and possible treatments, ranked for appropriateness based on the latest research and clinical expertise and experience. A physician enters a patient scenario into the tool, which signals whether certain treatment modalities fit into one of the following categories: appropriate, may be appropriate, or rarely appropriate.

Like all AUC, the Limb Salvage or Early Amputation tool presents a set of assumptions and disclaimer for the user to accept:

  • The AUC apply to adults (aged 17–64 years) with high-energy lower-extremity trauma (below the knee joint).
  • Consultations with trauma, vascular, and plastic surgeons have been undertaken as necessary.
  • Adequate distal perfusion is present or can be restored.
  • The AUC address only patients initially admitted to the hospital and prior to definitive wound closure.

Exclusions are stipulated for patients with traumatic amputation and for patients in extremis not rapidly correctable due to other systemic injuries and/or polytrauma (i.e., those who are not able to undergo immediate limb-salvage surgery or who may need immediate amputation for survival).

The AUC tool offers seven indication profiles covering injury variables, including limb site (leg, foot/ankle, or both), type and severity of injury, presence and degree of contamination, and comorbidities. When a user selects parameters, the tool makes
a recommendation in regard to salvage or amputation (Fig. 2). In some scenarios, a clear recommendation for one or the other is indicated, but for many situations, the tool indicates that either may be appropriate, meaning that further evaluation and application of clinical judgment are required for a definitive decision.

“This AUC [tool] is the result of a lively and candid discussion between experts in trauma care with many different perspectives,” said Benjamin J. Miller, MD, MS, FAAOS, who served as oversight chair.

“Our hope is that this instrument will help clinicians, patients, and family members make appropriate and informed medical decisions at the initial presentation of traumatic lower-extremity injuries, invariably a difficult and emotional time for all involved,” he added.