Standards for treatment of open lower limb fractures maintained in spite of the COVID-19 pandemic: Results from an international, multi-centric, retrospective cohort study.

Dear sir,

The COVID-19 pandemic has severely disrupted provision of healthcare services, impacting both emergency and elective pathways. In March 2020, the British Orthopaedic Association in conjunction with other relevant bodies published guidance for the treatment of limb-threatening injuries during the pandemic. These were designed to minimise the risks of patients contracting COVID-19 from prolonged inpatient stay and reduce the burden on stretched health services. They recommended that multiple and complex procedures should be avoided and the threshold for early amputation reduced.

The aim of this study was to assess the safety of care pathways for patients sustaining open extremity injuries during the first wave of the COVID-19 pandemic. Our primary objective was to investigate the risk of SARS-CoV-2 related complications in this group of patients, including death. As a secondary objective we intended to capture deviations from the standard of care usually provided for these injuries and associated outcomes. Given the burden of trauma in developing countries even before the pandemic, we examined the impact on a global scale.

Methodology

We conducted an international, multi-centric, retrospective study in patients with open lower limb fractures, of any severity, treated between the 1st January and 31st May 2020. Participating units in the UK and overseas provided anonymised data using a pre-established proforma on a secure REDCap platform. Approval by clinical audit departments and independent board review in each collaborating hospital was sought as per local protocols.

Results

A total of 212 patients from 15 centres in the United Kingdom (36%), Chile (20%), Sudan (14%), Spain (10%), the Netherlands (6%), Taiwan (5%), South Korea (5%), Mexico (2%) and Italy (2%) were included. Demographic data, injury characteristics, treatment received, and inpatient recovery were recorded (Table 1 ).

Table 1

Data gathered for cases submitted to the INTELLECT-COVID study. The second column presents results for the whole sample, with the following columns presenting national results for countries that represent 80% of included cases.

Demographics	Total (n = 212)	UK (n = 79)	Chile (n = 42)	Sudan (n = 29)	Spain (n = 21)
Mean age	46 years (range: 6–98)	47 years	38 years	35 years	52 years
Male: Female	74:26	70:30	83:17	93:7	62:38
Location of fracture	Femur: 15% / Tibia-fibula: 69% / Foot: 16%	Femur: 10% / Tibia-fibula: 77% / Foot: 13%	Femur: 45% / Tibia-fibula: 31% / Foot: 24%	Femur: 0% / Tibia-fibula: 85% / Foot: 15%	Femur: 10% / Tibia-fibula: 76% / Foot: 14%
Mechanism of injury	Road traffic accident: 54% / Low-energy fall: 19% / High-energy fall: 12% / Work-related: 11% / Other: 4%	Road traffic accident: 39% / Low-energy fall: 35% / High-energy fall: 18% / Work-related: 5% / Other: 3%	Road traffic accident: 64% / Low-energy fall: 0% / High-energy fall: 6% / Work-related: 25% / Other: 5%	Road traffic accident: 80% / Low-energy fall: 4% / High-energy fall: 0% / Work-related: 4% / Other: 12%	Road traffic accident: 38% / Low-energy fall: 33% / High-energy fall: 24% / Work-related: 5% / Other: 0%
Fracture classification (Gustilo-Anderson)	I: 20% / II: 37% / III A: 17%, B: 21%, C: 5%	I: 19% / II: 27% / III A: 13%, B: 38%, C: 3%	I: 18% / II: 66% / III A: 16%, B: 0%, C: 0%	I: 22% / II: 39% / III A: 14%, B: 22%, C: 3%	I: 24% / II: 37% / III A: 24%, B: 5%, C: 10%
Treatment and outcomes
Direct transfer to specialist centre	76%	80%	76%	62%	86%
Wound debridement within 24 h	77% / Median time to debridement: 11 h	72.2% / Median time to debridement: 20 h	93% / Median time to debridement: 5 h	66% / Median time to debridement: 10 h	86% / Median time to debridement: 9 h
Specialties involved in primary debridement	Orthopaedic surgeons: 64% / Plastic surgeons: 24.2% / Orthopaedic and plastic surgeons: 6.6% / Trauma surgeons: 5.2%	Orthopaedic surgeons: 34% / Plastic surgeons: 53% / Orthopaedic and plastic surgeons: 13% / Trauma surgeons: 0%	Orthopaedic surgeons: 95% / Plastic surgeons: 5% / Orthopaedic and plastic surgeons: 0% / Trauma surgeons: 0%	Orthopaedic surgeons: 86% / Plastic surgeons: 14% / Orthopaedic and plastic surgeons: 0% / Trauma surgeons: 0%	Orthopaedic surgeons: 95% / Plastic surgeons: 5% / Orthopaedic and plastic surgeons: 0% / Trauma surgeons: 0%
Median time to definitive skeletal fixation	2 days	1 day	1 day	4 days	5 days
Primary mode of definitive skeletal fixation	Casting: 5% / Uni-biplanar external fixator: 5% / Frame external fixator: 17% / Plate and screws: 32% / Intramedullary nail: 29% / Kirschner wires: 4% / Other: 8%	Casting: 8% / Uni-biplanar external fixator: 3% / Frame external fixator: 19% / Plate and screws: 23% / Intramedullary nail: 39% / Kirschner wires: 3% / Other: 5%	Casting: 0% / Uni-biplanar external fixator: 3% / Frame external fixator: 0% / Plate and screws: 52% / Intramedullary nail: 26% / Kirschner wires: 0% / Other: 19%	Casting: 10% / Uni-biplanar external fixator: 0% / Frame external fixator: 48% / Plate and screws: 14% / Intramedullary nail: 14% / Kirschner wires: 14% / Other: 0%	Casting: 5% / Uni-biplanar external fixator: 24% / Frame external fixator: 24% / Plate and screws: 24% / Intramedullary nail: 5% / Kirschner wires: 5% / Other: 13%
Soft tissue reconstruction required	36%	51%	19%	21%	19%
Median time to soft tissue closure	10 days	4 days	29 days	37 days	35 days
Modality of soft tissue closure (Total n = 76)	Conventional dressings: 3% / Negative pressure wound therapy: 5% / Skin grafting: 16% / Local flaps: 10% / Perforator flaps: 22% / Free flaps: 44%	Conventional dressings: 3% / Negative pressure wound therapy: 8% / Skin grafting: 13% / Local flaps: 11% / Perforator flaps: 21% / Free flaps: 45%	Conventional dressings: 0% / Negative pressure wound therapy: 0% / Skin grafting: 25% / Local flaps: 13% / Perforator flaps: 13% / Free flaps: 50%	Conventional dressings: 20% / Negative pressure wound therapy: 0% / Skin grafting: 40% / Local flaps: 20% / Perforator flaps: 20% / Free flaps: 0%	Conventional dressings: 0% / Negative pressure wound therapy: 0% / Skin grafting: 0% / Local flaps: 33% / Perforator flaps: 66% / Free flaps: 0%
Flap survival rates	Local and perforator flaps (n = 20): Total flap failure 5% / Partial flap failure: 10% / Total flap survival: 85%. Free flaps (n = 29): Total flap failure 6.8% / Partial flap failure: 6.8% / Total flap survival: 86.2%.
Unexpected return to theatre in first 30 days	8%	9%	0%	10%	5%
Amputation	Immediate: 1.4% / Early: 4.3%	Immediate: 1.2% / Early: 2.5%	Immediate: 0% / Early: 4.7%	Immediate: 3.4% / Early: 3.4%	Immediate: 0% / Early: 0%
Median time to discharge	13 days	14 days	10 days	6 days	11 days
Patients diagnosed with COVID pre-admission	0
Patients diagnosed with COVID during admission	1 (0.47%)
Missing data 0.83%

Despite the pandemic, all centres treated patients according to their usual standards with minimal deviation. Seven patients (3.3%) had their follow-up appointments delayed or adapted to telephone consultations. The majority underwent debridement in the first 24 h (73%), Median time to definitive skeletal fixation and soft tissue reconstruction, if required, from time of injury was two and ten days, respectively. Limbs preservation at discharge was achieved in 94.4% of the cases, with 12 patients (5.6%) requiring immediate or early amputation. Serious complications included three total (6%) and five partial flap failures (10%), 10 cases of acute wound infection (5%), two hematomas that required evacuation (1%) and two deep venous thrombosis (1%). Three patients in the flap failure group required further reconstruction: two with a local flap and one with a second free flap. Two patients in this cohort died because of their injuries and two succumbed to hospital acquired non-COVID pneumonias in the context of pre-existing COPD. No patients were diagnosed with SARS-CoV-2 prior to admission and only one tested positive as an inpatient (0.5%) on PCR and CT-scans and eventually made a full recovery.

Discussion

Even though there have not been any previous international studies of these characteristics, there are large cohort series published. For the UK subgroup, three of 79 patients (3.7%) required amputation which is similar to the recent UK WOLFF trial (2% of 460 cases). Partial and total free flap failure rates (6.8% for both) are also similar to those reported by a recent study of 129 patients treated in the United States, which reported 10.8% partial and 14.7% total flap failure, and 7.8% requiring amputation.

Our study is limited by its retrospective nature, geographic variability, different resource settings and limited follow up (1 to 105 days). This design was necessary to achieve a rapid and global response during the ongoing COVID-19 pandemic. The incidence of patients with COVID-19 in this international sample of emergency admissions was very low. Despite guidance advocating the avoidance of staged procedures and limb salvage in borderline situations, almost all patients received standard care.

Our data demonstrate that lower limb trauma services across many countries have managed to adhere to their usual pre-COVID standard of care. The outcomes so far have remained largely within modern acceptable outcomes. Provided standard surgical COVID-19 precautions are maintained, including screening patients with unknown COVID status upon admission, and routine use of personal protective equipment, it would be reasonable to follow pre-COVID guidance and expect similar outcomes during the current second wave of the pandemic.