Surgical Treatment, Reoperations, and Complications among Patients with Clavicle Fracture in England

Author(s)

Chitnis A1, A M2, Wolf S3, Vanderkarr M4, Quintana J5, Gador LV6, Holy CE1, Lambert S7
1Johnson & Johnson, New Brunswick, NJ, USA, 2Mu Sigma, Bengaluru, KA, India, 3Synthes GmbH, Zuchwil, Switzerland, 4DePuy Synthes, Inc., Bay Village, OH, USA, 5Johnson & Johnson, Madrid, M, Spain, 6Johnson & Johnson Medical GmbH, Norderstedt, Germany, 7NHS, London, UK

OBJECTIVES : Clavicle fractures are common. Surgical management has been associated with positive clinical and functional outcomes. However, there is limited real-world data concerning management and clinical burden in patients with clavicle fractures in England. This study evaluated rates of surgical treatment, reoperations, and post-surgical complications in patients with clavicle fractures using the Clinical Practice Research Datalink (CPRD) Database in England.

METHODS : Data from the CPRD was linked to National Health Service Hospital Episode Statistics datasets. Adult patients (≥18 years) with a diagnosis of clavicle fracture between 2010–2018 were identified. Date of fracture was defined as index time. Surgical treatment was evaluated at 45, 90, and 180 days post-index. Rates of complications (infection, non-union and mal-union) and reoperations, including device removal, and median time to device removal were evaluated 2 years after surgical treatment for patients with ≥2 years follow-up.

RESULTS : 21,340 patients with clavicle fractures were identified. The mean (standard deviation) age was 35.0 (26.5) years and 66.7% patients were male. The cumulative rates for surgical treatment were 2.8%, 3.0% and 3.2% at 45, 90, and 180 days after fracture. The rate of reoperations within 2 years after treatment was 22.7% (95% CI, 18.6%- 26.8%). Implant removal was the main reason for reoperation in 70.0% (95% CI, 60.2%- 79.0%). The median time to implant removal was 254 days. Over 2 years following surgery, the rate of infection was 3.5% (95% CI, 1.7%- 5.2%), non-union4.4% (95% CI, 2.4%- 6.5%) and mal-union 0.3% (95% CI, 0%- 0.7%).

CONCLUSIONS : Patients with surgical treatment for clavicle fracture experience high rates of reoperation, primarily for device removal. Other complications (infection, non-union and malunion) affected 8.1% of all surgically treated patients. New surgical techniques or devices that reduce the need for implant removal may address a significant clinical burden.

Conference/Value in Health Info

2021-05, ISPOR 2021, Montreal, Canada

Value in Health, Volume 24, Issue 5, S1 (May 2021)

Code

PMD15

Topic

Clinical Outcomes, Epidemiology & Public Health, Medical Technologies

Topic Subcategory

Clinical Outcomes Assessment, Medical Devices

Disease

Injury and Trauma, Medical Devices, Surgery

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