BRICS: Brazilian Multicentric Pragmatic Randomised Trial of Surgical Interventions for displaced Diaphyseal Clavicle Fracture Study - MIO vs ORIF for the treatment of displaced midshaft clavicle fractures

Fractures of the diaphysis of the clavicle are frequent, and the main treatment of this disease is still unknown. Surgery is associated with a lower risk of nonunion, better functional outcomes, but higher risk of complication. There are few comparisons between traditional and minimally invasive surgical techniques. The aim of this study is to evaluate, among individuals with displaced fracture of the clavicle diaphysis, which surgical treatment option (minimally invasive osteosynthesis or open reduction and internal fixation) has the superior performance considering complications and re-operations.

Journal Ref. Protocol Published at BMJ Open 2021;11:e052966. doi: 10.1136/bmjopen-2021-052966
Intervention Surgical - Minimally invasive techniques for displaced fracture of the clavicle diaphysis or open reduction and internal fixation with plate and screws
Number of sites 11
Countries involved 01
Sample size 190
Type of statistical analyses ITT - Intetion to Treat
Participant characteristics Age: adults (> 18y)
Condition: individuals with traumatica displaced diaphyseal clavicle fracture
Baseline severity: none
Duration of trial
Primary outcome The number of complications and re-operations (C&R) are proposed as primary outcome. Complications11 are considered as cases of infection (superficial or deep), hypertrophic scarring, pseudoarthrosis, refracture, implant failure, hypoesthesia, skin irritation and shoulder pain [except hypoesthesia]. Infections will be diagnosed clinically by evaluation of the surgical team, in the postoperative follow-up, in the presence of inflammatory signs around the surgical wound, with the presence or absence of secretions. Superficial infection will be classified as that which does not require, in the researcher's judgment, surgical debridement, indicating as treatment the use of oral antibiotics and ambulatory dressings. Deep infection will be considered to be one that requires surgical debridement procedure and, for that purpose, collection of biological material (soft tissue and / or bone fragments) will be instructed to prove the condition and laboratory tests (blood count, creatinine, PCR and ESR) to guide the participant's treatment. Pseudoarthrosis is defined as the non-consolidation of the fracture in clinical and radiographic evaluation29. Hypoesthesia is considered as the decrease in sensitivity to light touch in the region around the surgical scar30. Skin irritation is defined as the patient's feeling of discomfort related to the presence of the implant13. Re-operations are defined as the number of surgical procedures performed for the treatment of pseudoarthrosis, implant failure, debridement of deep infection and programmed removal of the implant. The primary outcome will be assessed for 24 weeks and any complication that meets any of the above criteria during this follow-up will be counted as one occurrence of complication.
Show Score Ranges


(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4 5 5 4 4 0 4 4 5