The Lower Extremity Assessment Project (LEAP) study has been a landmark effort in the field of orthopaedic trauma. By evaluating the outcomes of limb-threatening lower-extremity injuries and relating those outcomes to various injury and treatment-related factors, these investigators are improving the care of these challenging injuries.
The study by Webb et al. in this issue of The Journal examines whether surgeon-controlled factors, such as the timing of initial débridement, timing of definitive soft-tissue coverage, time of bone-graft placement, and method of stabilization, influence outcome. A subset of 156 patients who were enrolled in the LEAP study and who had severe isolated open tibial-shaft fractures (Gustilo type IIIA, IIIB, and IIIC) were reviewed. One hundred and five patients underwent limb salvage, and the other fifty-one patients underwent early amputation. For the patients who had limb salvage, the outcome was determined on the basis of an orthopaedic assessment of fracture-healing and complications of treatment two years after the injury. Patient-derived outcome scores, which were determined by computation of the physical and psychosocial subscales of the Sickness Impact Profile, were obtained by telephone interview at intervals up to seven years following injury; seven-year data were obtained for 78% of the patients. The complications and outcome scores following limb salvage were then related to aspects of treatment that the surgeon was able to influence.
In this study, which was performed at Level-I trauma centers, the timing of débridement (within six hours after injury as the threshold) and the timing of soft-tissue coverage (within three days after injury as the threshold) had no apparent effect on clinical or functional outcome when examined two to seven years later. Although these results may seem surprising given the nearly universally accepted teaching that early débridement and early soft-tissue coverage are key factors in reducing complications of open fractures, the findings are actually consistent with other recently published data1-3. The authors of this study also found that the timing of bone-grafting had no impact on outcome. This matter has been more controversial in the literature, with data supporting both early4 and delayed5 bone-grafting of open tibial fractures. The findings with respect to the higher rates of reoperation, prolonged time to full weight-bearing, and increased number of days in the hospital in patients treated definitively with external fixation are less surprising and support current recommendations for early exchange to an intramedullary nail whenever possible. The finding that patients who required both external fixation for definitive stabilization and muscle-flap coverage had more impairment than those who had an amputation is an important finding that may give clinicians a reasonable benchmark for future decision-making regarding limb salvage.
These findings add to the important contributions of the LEAP study. However, the reader should be aware that this paper represents a post hoc subgroup analysis of a larger data set. Therefore, it is important to realize that these data are not the final word and ideally would be confirmed by a clinical trial specifically designed to address these questions. Since a randomized clinical trial evaluating the timing of surgery would be all but impossible to perform for a variety of logistical and ethical reasons, data such as these may be the best we can hope to have. Despite the "negative" findings found in this study, it is this reviewer's opinion that a surgeon should still strive to perform appropriate surgical débridement of severe open tibial shaft fractures as soon as possible.
*The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the author, or a member of his immediate family, is affiliated or associated.
1. Skaggs DL, Friend L, Alman B, Chambers HG, Schmitz M, Leake B, Kay RM, Flynn JM. The effect of surgical delay on acute infection following 554 open fractures in children. J Bone Joint Surg Am. 2005;87:8-12.
2. Khatod M, Botte MJ, Hoyt DB, Meyer RS, Smith JM, Akeson WH. Outcomes in open tibia fractures: Relationship between delay in treatment and infection. J Trauma. 2003;55:949-54.
3. Harley BJ, Beaupre LA, Jones CA, Dulai SK, Weber DW. The effect of time to definitive treatment on the rate of nonunion and infection in open fractures. J Orthop Trauma. 2002;16:484-90.
4. Fischer MD, Gustilo RB, Varecka TF. The timing of flap coverage, bone-grafting, and intramedullary nailing in patients who have a fracture of the tibial shaft with extensive soft-tissue injury. J Bone Joint Surg Am. 1991;73:1316-22.
5. Kesemenli CC, Kapukaya A, Subasi M, Arslan H, Necmioglu S, Kayikci C. Early prophylactic autogenous bone grafting in type III open tibial fractures. Acta Orthop Belg. 2004;70:327-31.