LEAP Study
An Analysis of Outcomes of Reconstruction or Amputation after Leg-Threatening Injuries
Bosse MJ · N Engl J Med · 2002
This prospective multicentre study compared functional recovery between limb salvage and primary amputation in severe lower-extremity trauma, finding equivalent two-year functional outcomes alongside substantial persistent disability in both cohorts.
Citation & links
Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31.
Key findings
- 1.At two years, overall functional outcomes assessed by the Sickness Impact Profile showed no significant difference between the amputation and reconstruction groups (mean SIP score: 12.6 vs. 11.8, P = 0.53).
- 2.Patients in both groups experienced high degrees of residual disability, with average SIP scores markedly worse than baseline population norms (typical general population score: 2 to 3).
- 3.Patients undergoing limb reconstruction faced significantly higher rates of hospital readmission for major complications compared to amputees (47.6% vs. 33.9%, P = 0.002).
- 4.Employment rates at two years were comparable and relatively low in both arms (53.0% for amputees vs. 49.4% for reconstructed patients).
- 5.Functional recovery was predominantly determined by socioeconomic and psychological factors—such as poverty, lower education, lack of private health insurance, poor social support, pending litigation, and low self-efficacy—rather than the initial treatment decision itself.
Background
Technological and microvascular surgical advances have made limb salvage technically achievable in limbs that previously necessitated amputation. However, it remained unclear whether preserving a severely traumatised limb resulted in better functional, social, and psychological outcomes than early amputation. The LEAP study addressed this fundamental question to guide shared clinical decision-making.
Methods
A prospective, observational cohort study was conducted across eight Level I trauma centres in the United States involving 569 patients (aged 16–69 years) with severe lower-limb injuries, including Gustilo-Anderson type IIIB and IIIC open tibial fractures, vascular trauma, and severe hindfoot injuries. Patients underwent either surgical reconstruction or amputation. Functional status was evaluated at two years using the Sickness Impact Profile (SIP), where scores exceeding 10 signify severe overall disability.
Clinical implications
The findings reshaped orthopaedic trauma philosophy by illustrating that technical feasibility of limb salvage does not guarantee superior long-term function compared to early amputation. Surgeons can counsel patients that functional recovery at two years is similar, but reconstruction involves substantially more surgical procedures and higher readmission rates. Furthermore, clinical outcome prognostication must account heavily for social determinants of health and baseline psychosocial resilience.
Critical appraisal
Strengths include the prospective multicentre design, rigorous cohort tracking, adjustment for confounders, and use of validated general health outcome measures across eight major trauma centres. Limitations stem from its observational nature without randomisation (treatment allocations were influenced by injury complexity and surgeon/patient choice), and the fact that long-term prosthetic technological advancements and modern limb reconstruction techniques have evolved considerably since publication.
Teaching note
A core exit-exam landmark: know that at two years, functional outcomes (SIP scores) between amputation and reconstruction are equivalent, both groups display significant long-term disability, reconstruction has significantly higher rehospitalisation rates (~48% vs ~34%), and socioeconomic/psychological variables predict functional recovery more strongly than the chosen operative pathway.
Exam-tested points
- ›Functional outcomes measured via the Sickness Impact Profile (SIP) are statistically equivalent between limb reconstruction and amputation at 2 years.
- ›Patients undergoing limb reconstruction experience a significantly higher rate of major complications requiring readmission (47.6% vs 33.9%).
- ›Both treatment groups exhibit severe long-term disability (mean SIP > 10, compared to a population normal baseline of 2–3).
- ›Return-to-work rates at two years are virtually identical between reconstruction (~49%) and amputation (~53%).
- ›Patient-level determinants (poverty, educational attainment, social support, self-efficacy, smoking, pending litigation) exert a greater influence on functional recovery than the decision to reconstruct versus amputate.
- ›Corroborating LEAP sub-studies showed that an insensate plantar foot at presentation does not reliably predict long-term sensory function and should not be used as an absolute indication for primary amputation.
Test yourself on Trauma
Practise SBA questions covering this subspecialty.