Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jan;46(1):21-27.
doi: 10.1007/s00264-021-04990-x. Epub 2021 Feb 26.

Off-label use of orthopedical trauma implants in a low-income country

F Wichlas  1   2 , V Hofmann  1   2 , G Strada  3 , M Moursy  1 , C Deininger  4   5
Affiliations

Off-label use of orthopedical trauma implants in a low-income country

F Wichlas et al. Int Orthop. 2022 Jan.

Abstract

Purpose: Lack of resources, severe injuries, and logistical flaws force surgeons in low-income countries (LIC) to improvise during surgery and use implants "off-label." These off-label treatments are specific for the work of trauma surgeons in non-governmental (NGO) hospitals in LIC. The aim of this study is to show the need of off-label surgery in an environment of low resources by means of typical examples.

Methods: Off-label treated fractures, the implant used instead, and the reason for off-label treatment were investigated in 367 injuries over a three month period in an NGO hospital in Sierra Leone.

Results: Twenty-seven fractures were treated off-label with mostly K-wires (88.89%) and external fixators (51.85%). Three reasons for off-label use could be defined: no suitable implants (N = 14), the condition of soft tissues that did not allow internal osteosyntheses (N = 10), and implants not ready for surgery due to logistic flaws (N = 3). The implants needed were mostly locking plates.

Conclusion: Surgeons in similar settings must use K-wires and external fixators to treat complex fractures. Using implants off-label can help surgeons to treat fractures otherwise left untreated.

Keywords: Austere environment; Complex injuries; External fixators; K-wires; LIC; NGO surgery; Off-label treatment.

PubMed Disclaimer

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
No implant. A 35-year-old male sustained a road traffic accident with I ° closed femoral fracture AO 33 A1, left side. The fracture extends into the articular surface. Pre-operative anteroposterior and lateral X-ray of the fractured femur (a and b). In HIC, a locking plate would be the implant of choice. We fixed the articular surface and the shaft component with two screws each (4.5 mm cortex screws and 6.5 mm cancellous screws, steel) and the locking plate was replaced by an external fixator. Anteroposterior and lateral X-ray 8 weeks postoperatively of the left femur showing the osteosynthesis in place and callus formation on the fracture site (c and d). Postoperative treatment was partial weight bearing and no limitation for knee and hip
Fig. 2
Fig. 2
Condition of soft tissue. Severe forearm injury, treated off -label because of III°B open soft tissue injury. This 41-year-old male patient got in a traffic road accident and injured his right forearm (Fracture AO 2R2A2/2U2C2, G III° B open, compartment syndrome). The patient claimed that a car rolled over his forearm. The initial treatment was external fixation and dorsopalmar dermatofasciotomy. The fixation of the ulna was later aligned with an intramedullary K-wire, the palmar wound closed, and the dorsal one was mesh grafted. Although the external frame fixation might not be very common, external fixation is the treatment of choice for open fractures. To achieve a better alignment and increase the chance for orthograde healing, we decided to add an intramedullary K-wire for the ulna. Intramedullary K-wires are unusual or off-label for forearm fractures in adults. Posterior (a) and anterior (b) clinical picture after dorsopalmar dermatofasciotomy and application of an external fixator
Fig. 3
Fig. 3
Anterior and lateral preoperative X-ray of the fractured forearm (a and b), III°B open of the patient mentioned in Fig. 2. Post-operative anteroposterior and lateral X-ray of the forearm showing the external fixator in place (c and d). Post-operative anteroposterior and lateral X-ray of the forearm showing the external fixator and an intramedullary K-wire to align the fracture (e and f). The K-wire was inserted at the last surgery before the skin was closed
Fig. 4
Fig. 4
Implant not ready. A 34-year-old female patient sustained a III°B open tibial fracture AO 42 A2.3 by a road traffic accident. Anteroposterior and lateral X-ray of the fractured lower leg, III°B open (a and b). The patient was planned for external fixation as an emergency procedure. At the time of operation, no external fixator was ready in the OT. After debridement, we decided to fix the fracture with K-wires additionally to a cast. The K-wires should provide an anatomic reduction that the cast alone could not. The three intrafocal K-wires should hold the reduction of the tibia, the intramedullary K-wire align the fibula, and the two fibulotibial K-wires act as a frame fixation (c and d). As the K-wires would become loose and migrate, their intention is to hold the anatomic reduction as long as possible
See this image and copyright information in PMC

Comment in

References

    1. Bhangu A, Ademuyiwa AO, Aguilera ML et al (2018) Surgical site infection after gastrointestinal surgery in high-income, middle-income, and low-income countries: a prospective, international, multicentre cohort study. Lancet Infect Dis 18:516–525. 10.1016/S1473-3099(18)30101-4 - PMC - PubMed
    1. Alibhai A, Hendrikse C, Bruijns SR (2019) Poor access to acute care resources to treat major trauma in low- and middle-income settings: a self-reported survey of acute care providers. Afr J Emerg Med 9:S38–S42. 10.1016/j.afjem.2019.01.004 - PMC - PubMed
    1. Blair KJ, Paladino L, Shaw PL et al (2017) Surgical and trauma care in low- and middle-income countries: a review of capacity assessments. J Surg Res 210:139–151. 10.1016/j.jss.2016.11.005 - PubMed
    1. Spiegel DA, Nduaguba A, Cherian MN et al (2015) Deficiencies in the availability of essential musculoskeletal surgical services at 883 health facilities in 24 low- and lower-middle-income countries. World J Surg 39:1421–1432. 10.1007/s00268-015-2971-2 - PubMed
    1. Sheth NP, Hardaker WM, Zakielarz KS et al (2018) Developing sustainable orthopaedic care in Northern Tanzania: an international collaboration. J Orthop Trauma 32(Suppl 7):S25–S28. 10.1097/BOT.0000000000001296 - PubMed

Publication types

LinkOut - more resources