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Clinical Management Update

Practice Management Guidelines for the Optimal Timing of Long-Bone Fracture Stabilization in Polytrauma Patients: The EAST Practice Management Guidelines Work Group

Dunham, C. Michael MD; Bosse, Michael J. MD; Clancy, Thomas V. MD; Cole, Frederic J. Jr., MD; Coles, Maxime J. M. MD; Knuth, Thomas MD; Luchette, Fred A. MD; Ostrum, Robert MD; Plaisier, Brian MD; Poka, Attila MD; Simon, Ronald J. MD

Author Information
The Journal of Trauma: Injury, Infection, and Critical Care: May 2001 - Volume 50 - Issue 5 - p 958-967
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I. STATEMENT OF THE PROBLEM

The optimal timing for long-bone stabilization in polytrauma patients has been debated for the last two decades. Much of the relevant literature focused on long-bone fracture as a femoral fracture; however, a substantial portion of published studies include various fractures (tibia, humerus, spine, and/or pelvis). Reported benefits of early long-bone stabilization in polytrauma patients include increased patient mobilization by eliminating the need for traction and decreased pulmonary morbidity (fat emboli syndrome, pneumonia, adult respiratory distress syndrome [ARDS]), late septic sequelae, hospital care costs, mortality, hospital length of stay (LOS), intensive care unit (ICU) LOS, and ventilator days. Some authors suggest that early long-bone stabilization in polytrauma patients increases blood loss, fluid administration, and surgical stress, pulmonary morbidity, and mortality. However, others intimate that pulmonary morbidity (pulmonary shunt) is similar in those undergoing early or late stabilization (i.e., no worse, no better). There have been additional concerns regarding the timing of long-bone stabilization in patients with brain or chest injury. Problems with early fixation of long bones in patients with brain injury include secondary brain injury as a result of hypoxemia, hypotension, and/or complexity of controlling intracranial hypertension, increased mortality, and increased fluid administration, which might exacerbate cerebral edema. Other investigators suggest that early long-bone stabilization is not advised in patients with pulmonary contusion, multiple rib fractures, or hemopneumothorax, since there is increased pulmonary morbidity (ARDS, fat embolism syndrome), especially when intramedullary nailing and reaming are used. However, others indicate that chest injury patients with early intramedullary nailing have similar outcomes compared with later intramedullary nailing or other stabilization techniques (i.e., no worse or better). Other studies suggest that pulmonary contusion patients have similar pulmonary morbidity (Pao2/Fio2 and duration of mechanical ventilation) with early or late stabilization (i.e., no worse or better).

II. PROCESS

A. Identification of References

Literature searches were conducted using MEDLINE, OVID Technologies, Inc., and EMBASE. Literature survey parameters included studies written in the English language using human subjects, and which were published between 1980 and 1998.

MEDLINE MESH Search
  • 1. Femoral fracture/fractures/fracture fixation and thoracic injuries: 414 articles found; only 12 with potential relevance.
  • 2. Fracture fixation/femoral fractures and head injuries/brain injuries: 666 articles found; only 18 with potential relevance.
  • 3. Fractures/femoral fractures/fracture fixation and multiple trauma: 378 articles found; only 59 with potential relevance.
  • 4. Femoral fractures/fracture fixation/fractures and respiratory insufficiency/respiratory distress syndrome, adult/respiration: 158 articles found; only 34 with potential relevance.
MEDLINE Title Strategy

Additional articles were sought by using the following title searches: (1) timing fixation, (2) delayed fixation, (3) early fixation, (4) early osteosynthesis, (5) immediate fixation, (6) timing fracture, (7) timing osteosynthesis, (8) fracture: brain, (9) fracture: chest, (10) fem: multiple, (11) fem: poly, (12) fracture: thoracic, (13) fracture: multiple, (14) fracture: poly, (15) fixation multiple, (16) fixation poly, and (17) fracture: head.

Other MEDLINE Literature Search Strategies

The bibliography of the relevant articles mentioned previously was reviewed to find additional potentially appropriate publications.

EMBASE Literature Search Strategies

OVID Technologies, Inc., used EMBASE, a medical literature database distinct from the National Library of Medicine, to perform similar “MESH” and title searches as described above for the MEDLINE searches. The MESH strategy identified 1,462 potentially relevant articles and the title search method captured 351 such articles.

Inclusion in Evidentiary Tables

Articles retrieved from the above process were selected for inclusion if they met the following criteria: (a) the blunt trauma mechanism was high-energy, (b) each patient had a long-bone injury, (c) each patient had a major non–long-bone injury, and (d) there was an early and a late group undergoing fracture stabilization.

B. Quality of the References

The quality assessment instrument applied to the references was developed by the EAST Practice Management Guidelines Committee. Articles were classified as Class I, II, or III according to the following definitions:

  • Class I: A randomized clinical trial. There were no Class I articles identified.
  • Class II: A prospective, noncomparative clinical study or a retrospective analysis derived from reliable data.
  • Class III: A retrospective case series or database review.

III. RECOMMENDATIONS

A. Level I

Definition: This recommendation is convincingly justifiable on the basis of the available scientific information alone. It is usually derived from Class I data; however, strong Class II evidence may form the basis for a Level I recommendation. There is insufficient evidence to support a standard of care on this topic.

B. Level II

Definition: This recommendation is reasonably justifiable by available scientific evidence. It is usually supported by Class II data or a preponderance of Class III evidence.

  • 1. Polytrauma patients undergoing long-bone stabilization within 48 hours of injury have no improvement in survival when compared with those receiving later stabilization; however, there may be some patients who will have fewer complications. There is no evidence that early stabilization has any detrimental effect. It is preferable to perform early long-bone stabilization in polytrauma patients.
  • 2. There is no compelling evidence that early long-bone stabilization in mild, moderate, or severe brain injured patients either enhances or worsens outcome. The timing of long-bone stabilization should be individualized according to the patient’s clinical condition.
  • 3. There is no compelling evidence that early long-bone stabilization in patients with chest injury alters outcome. The timing of long-bone stabilization should be individualized according to the patient’s clinical condition.

IV. SCIENTIFIC FOUNDATION

Since the literature describes patients with injuries to the non–long-bone body region, which includes brain injury, chest injury, or mixed injury (the nonfracture injury is variable), and the clinical problems are often distinct, the scientific evidence is organized accordingly. Each study selected has an early and a late group according to the timing of fracture stabilization after injury. Almost all articles describe a clearly delineated number of hours or days for the timing of stabilization. However, a few only indicate “early” or “late” intervention and are typically excluded from this evaluation (see Evidentiary Tables [Tables 1–3]). Most investigations demonstrate similar injury severity between the early and late stabilization groups; however, it is clear that the magnitude of injury is different between the two groups in some studies. When the latter exists, those investigations are usually excluded from the final outcome analysis (see Evidentiary Tables [Tables 1–3]). Most studies indicate that the long-bone injury is a femoral fracture; however, several publications include patients with only a tibial, pelvic, humeral, or spinal fracture (see Evidentiary Tables [Tables 1–3]). Mortality and nonmortality outcomes are evaluated to determine whether the early fracture stabilization group has a similar, beneficial, or detrimental effect relative to the late group (see Evidentiary Tables [Tables 1 through 3]). An outcome between the early and late group is considered to be different in a given study when the p value is < 0.05. A few studies considered and cited in the Evidentiary Tables have such severe methodologic flaws that they are not included in the final outcome analysis. 1–4 Study defects included (a) early and late group patients from different time periods and different treating institutions, 1 (b) early group patient categorization despite stabilization as late as 4 days after injury and patients in the late group that had early stabilization with an external fixator, 2 and (c) failure to provide injury severity indices to determine the presence or absence of polytrauma and failure to include a late stabilization group. 3,4

Table 1
Table 1:
Evidentiary Table: Must Be Polytrauma and Have An Early and Late Fixation Group—Mixed Injury Patient Group
Table 1
Table 1:
Continued
Table 2
Table 2:
Evidentiary Table: Must Be Polytrauma and Have an Early and Late Fixation Group—Brain Injury Patient Group
Table 2
Table 2:
Continued
Table 3
Table 3:
Evidentiary Table: Must Be Polytrauma and Have an Early and Late Fixation Group—Chest Injury Patient Group

Mixed Injury Group (Divergent Non–Long-Bone Injuries)

Class II and III studies are combined to provide a more valid and comprehensive understanding of the data results. Polytrauma patients undergoing long-bone stabilization within 48 hours of injury have no improvement in survival when compared with those receiving later stabilization;5–13 however, there may be a reduction in the number of days of mechanical ventilation, 5,7,10–13 ICU 5–7,10–14 or hospital LOS, 5–8,10,12–14 incidence of ARDS, 6,7,9–11,16 pulmonary complications, 5–7,14,16 pneumonia, 6,7,11 or systemic infection. 5,10,11,13 The outcome summary is presented in Table 4. In essence, polytrauma patients undergoing long-bone stabilization within 48 hours of injury have no improvement in survival when compared with those receiving later stabilization; however, there may be some patients who will have fewer morbidities. There is no evidence that early stabilization has any detrimental effect.

Table 4
Table 4:
Mixed Injury Group: Class II and III Data Outcome Summary (12 Studies)—Early Group versus Late Group

Brain Injury Group

Class II Data

One study focuses on patients with severe traumatic brain injury, 8 whereas the other comingles those with mild, moderate, or severe traumatic brain injury. 12 Patients with mild, moderate, or severe brain injury undergoing long-bone stabilization within 48 hours of injury have similar rates for mortality, 8,12 ICU LOS, 12 mechanical ventilation requirements, 12 and total hospital LOS 8,12 when compared with those receiving later stabilization. The outcome summary is presented in Table 5. There is no compelling evidence that early long-bone stabilization in mild, moderate, or severe brain injured patients either enhances or worsens outcome.

Table 5
Table 5:
Brain Injury Group: Class II Data Outcome Summary (2 Studies)—Early Group versus Late Group
Class III Data

Four studies address those with severe traumatic brain injury, 17–20 and three investigations evaluate those with mild, moderate, or severe brain injury. 21–23 Patients with mild, moderate, or severe brain injury undergoing long-bone stabilization within 48 hours of injury have similar rates for mortality, 17,18,20–23 ICU LOS, 17,20–21 mechanical ventilation requirements, 20,21 total hospital LOS, 17,20,21 central nervous system (CNS) outcome 10,11,13 and adverse CNS event, 18,20,21,23 ARDS, 23 pulmonary complications, 23 pneumonia, 20 and systemic infection rate, 23 when compared with those receiving later stabilization. The outcome summary is presented in Table 6. These data support the Class II data study findings.

Table 6
Table 6:
Brain Injury Group: Class III Data Outcome Summary (7 Studies)—Early Group versus Late Group

Chest Injury Group

Class II Data

Patients with chest injury undergoing long-bone stabilization within 48 hours of injury have similar rates for mortality, 7,8,12 ARDS, 7 mechanical ventilation requirements, 7,12 ICU LOS, 7,12 and total hospital LOS, 7,8,12 when compared with those receiving later stabilization. The outcome summary is presented in Table 7. There is no compelling evidence that early long-bone stabilization in patients with chest injury either enhances or worsens outcome.

Table 7
Table 7:
Chest Injury Group: Class II Data Outcome Summary (4 Studies)—Early Group versus Late Group
Class III Data

Patients with chest injury undergoing long-bone stabilization within 48 hours of injury may have a worse ARDS rate;11,15 however, the mortality, 11,24 pulmonary complication 24,25 and pneumonia 11 rates, ventilator days, 11,24 and ICU LOS 11,24 are similar when compared with those receiving later stabilization. The outcome summary is presented in Table 8. These data support the Class II data study findings.

Table 8
Table 8:
Chest Injury Group: Class III Data Outcome Summary (4 Studies)—Early Group versus Late Group

V. SUMMARY

For several decades, there has been a debate regarding the optimal timing of long-bone fracture stabilization in polytrauma patients who may or may not have a brain or chest injury.

  • Mixed injury group: Polytrauma patients undergoing long-bone stabilization within 48 hours of injury have no improvement in survival when compared with those receiving later stabilization; however, there may be some patients who will have fewer morbidities. There is no evidence that early stabilization has any detrimental effect. It is preferable to perform early long-bone stabilization in polytrauma patients.
  • Brain injury group: There is no compelling evidence that early long-bone stabilization in mild, moderate, or severe brain injured patients either enhances or worsens outcome. The timing of long-bone stabilization should be individualized according to the patient’s clinical condition. Clinical factors that may be relevant to determine the appropriateness of early long-bone stabilization include (a) severity of the brain injury (Glasgow Coma Scale score, brain computed tomographic scan findings, and intracranial pressure), (b) severity of pulmonary dysfunction (Pao2/Fio2, lung compliance, and positive end-expiratory pressure requirement), (c) hemodynamic status, (d) estimated operative time, (e) estimated blood loss, and (f) open or closed fracture status.
  • Chest injury group: There is no compelling evidence that early long-bone stabilization in patients with chest injury either enhances or worsens outcome. The timing of long-bone stabilization should be individualized according to the patient’s clinical condition. Clinical factors that may be relevant to determine the appropriateness of early long-bone stabilization include (a) severity of pulmonary dysfunction (Pao2/Fio2, lung compliance, and positive end-expiratory pressure requirement), (b) hemodynamic status, (c) estimated operative time, (d) estimated blood loss, and (e) open or closed fracture status.

VI. FUTURE INVESTIGATION

Since there are no data Class I studies and only 6 (27.3%) of the 22 relevant studies are data Class II, there is a clear need for large, randomized studies. The following factors should be considered in the design of any future investigation:

  • Inclusion criteria: Patients should have similar long-bone injury, most likely a femoral fracture; there should be a non–long-bone injury Abbreviated Injury Scale (AIS) ≥2 (possibly AIS ≥ 3); a consecutive patient cohort should be used, with clear exclusion criteria for those not entering the study.
  • Patient characteristics: Grade of fracture (open [III vs. I/II] vs. closed); location of fracture (proximal, shaft, distal); method of initial long-bone stabilization (intramedullary nail [with or without reaming], external fixation, plates, and screws); degree of hemodynamic instability in first 6 hours (grade by blood loss, base deficit, hypotension, etc.); degree of brain injury (mild, moderate, or severe) (grade by best Glasgow Coma Scale score in first 6 hours and brain AIS); degree of chest injury (grade by lowest Pao2/Fio2 in first 6 hours and chest AIS).
  • Subgroups according to timing of long-bone stabilization: (1) ≤ 24 hours versus 25 to 48 hours versus > 48 hours or (2) ≤ 48 hours versus > 48 hours.
  • Delineation of relevant outcome variables: Mortality rate (hospital vs. 30-day); nonmortality outcomes: strict criteria for outcome variable definitions (e.g., pneumonia, ARDS); a priori ranking as to the importance of the various outcome variables; variables to be considered include ARDS, non-ARDS pulmonary complications, ventilator days, pneumonia, systemic infections, multiple organ failure, hospital and/or professional costs, ICU LOS, total hospital LOS, intraoperative complications (hypotension, hypoxemia), adverse CNS events, and CNS outcome.

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© 2001 Lippincott Williams & Wilkins, Inc.