Treatment, Complications, and Costs in Clavicle Fracture and Acromioclavicular Dislocation

Study type
Protocol
Date of Approval
Study reference ID
19_185
Lay Summary

Electronic medical records leverage data originating from clinical practice and provide an opportunity to assess the effectiveness of treatments in large numbers of patients treated in real-world settings. This observational evidence can assist clinicians, purchasers, consumers, and policymakers in making more informed decisions that can improve healthcare at the individual and population levels. Data regarding the clinical and economic burden and treatment pathways associated with clavicle fractures and acromioclavicular (AC) dislocation is sparse. This study aims to determine the rates of surgical treatment of clavicle fractures and AC dislocation. The study further aims to determine the rates of complications and costs among patients undergoing surgical treatment of clavicle fracture and AC dislocation.

Technical Summary

Clavicle fractures are common fractures that result from direct or indirect trauma to the shoulder region. Criteria for nonsurgical or surgical management of clavicle fractures are not clearly established. AC dislocation is a common shoulder injury typically due to direct trauma. Minor injuries (Types I and II) are typically managed nonoperatively, and more severe injuries (Types IV, V, and VI) are often referred to an orthopedic specialist for surgical consideration. Whether surgery is indicated for Type III AC joint injuries remains controversial. Data regarding the clinical and economic burden and treatment pathways and outcomes associated with clavicle fractures and AC dislocation is sparse. This study will assess rates of surgical treatment, post-surgical complications (infection, non-union, mal-union), reoperations, and reimbursement in patients with clavicle fractures and AC dislocations. Patients with ?1 diagnosis of clavicle fracture or AC dislocation (index) between 2010-2017 will be identified. Surgical treatment will be defined as a procedure within four weeks after clavicle fracture or AC dislocation. Rates of complications (infection, non-union, mal-union) and reoperations among surgical patients will be evaluated two years post-index. Reoperations will be defined as device-related e.g. removal of implant(s), or fracture or dislocation-related e.g. revision surgical procedures. All-cause healthcare costs will be evaluated over the two-year follow-up for surgical patients.

Health Outcomes to be Measured

This is a descriptive study and the key variables of interest include surgical treatment of clavicle fractures and AC dislocation; infection, non-union, mal-union and reoperations associated with surgical treatment of clavicle fracture and AC dislocation; healthcare costs for patients with clavicle fracture and AC dislocation surgery

Collaborators

Abhishek Chitnis - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Abhishek Chitnis - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Chantal Holy - Collaborator - Johnson & Johnson ( JnJ - USA )
Charisse Sparks - Collaborator - Johnson & Johnson ( JnJ - USA )
Cindy Tong - Collaborator - Johnson & Johnson ( JnJ - USA )
Simon Lambert - Collaborator - University College London Hospitals
Simone Wolf - Collaborator - Synthes GmbH
Thibaut Galvain - Collaborator - Johnson & Johnson Medical SAS

Linkages

HES Admitted Patient Care