Eligibility criteria.

All adult patients (>18 older) presenting at the emergency department (ED) or outpatient clinic with midshaft clavicle fractures (Robinson Type II or AO/OTA 15.2) [9] will be included. In-and exclusion criteria are shown in Fig 2. Patients will be screened for eligibility by the treating physician at presentation to the emergency department or during outpatient visits (within two weeks after trauma).

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Fig 2. In/exclusion criteria.

https://doi.org/10.1371/journal.pone.0291238.g002

Participant recruitment and screening.

Patients will be asked to participate in the study after the established decision on operative treatment. If eligible, the treating physician or local investigator will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits, and any discomfort it may entail. Each participant will be informed that participation in the study is voluntary, that he or she may withdraw from the study at any time, and that withdrawal of consent will not affect his or her subsequent medical assistance and treatment. The participant will be informed that their pseudonymized medical records may be examined by authorized researchers other than their treating physician.

Data management.

Data will be stored in pseudonymized form in an encrypted online database by the local investigators, which can access their respective individual patient data. Full access to the database is granted to the study coordinator.

Low-profile double plating group.

Low-profile double plating consists of one Stryker VariAx 2.0mm plate positioned on the superior aspect of the clavicle and a second Stryker VariAx 2.4mm or 2.7mm on the anterior side. Use of this implant will be according to the manufacturer’s indication of use.

Single plating group.

The choice of implant used for single plating is left at the discretion of the treating surgeon and the availability of implants in participating centers. Possible implants consist of 2.7 and 3.5mm plates placed on the superior or anterior side.

Standardization of care.

Preoperative care will consist of general anesthesia and routine antibiotic prophylaxis. Incision and cutaneous nerve sparing are left at the treating surgeon’s discretion and will be mentioned in the operation report. In case of a multi-fragmentary fracture pattern, bridge plating will be performed. In case of a simple fracture, a neutralization plate (with or without lag screws) or a compression plate will be used. Closure of deltopectoral fascia with absorbable braided sutures and skin with nonabsorbable monofilament sutures (Allgöwer-technique) will be performed for all patients. Operations will either be performed or directly supervised by a specialized trauma surgeon. Aftercare comprises a sling for comfort for 1–2 weeks, no weight bearing for six weeks, and outpatient clinic visits, including AP and axial clavicle X-rays at six weeks, three months, and one year after surgery in both treatment groups.

Study outcomes.

The primary outcome of this study is the number of re-interventions after two years of follow-up. Secondary outcomes include the number of re-interventions at one year of follow-up, all complications such as fracture-related infection [10], (a)symptomatic non-union, numbness below the scar, and self-reported implant irritations, disability of the shoulder and arm (DASH) score, EuroQol (EQ)-5D score, and the visual analogue scale (VAS) score for pain and patient satisfaction at 3, 12, and 24 months follow-up. A complete overview of the primary and secondary outcomes can be found in Table 1.

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Table 1. Primary and secondary outcomes.

https://doi.org/10.1371/journal.pone.0291238.t001

The outcome measure, follow-up and timeline.

At baseline, the treating physician or local investigator will collect the following characteristics: age, gender, body mass index (BMI), smoking status, comorbidities, medication, trauma mechanism, concomitant injuries and planned operative procedure (including treating hospital and surgeon), pre-injury DASH and EQ-5D-5L. The x-ray at presentation or outpatient clinic visit will be used to determine fracture type and dislocation. Fracture type will be determined according to the AO/OTA classification system for midshaft clavicle fractures [9]. Patients will receive the operation within two weeks of presentation. All operative data including interval between trauma and surgery, level of experience of surgeon, type of plate used, plate position, number and type of screws, type and length of incision and surgery duration will also be collected after the surgical procedure.

The patients will return to the outpatient clinic at three and twelve months. The outpatient clinic visit will include several questionnaires (e.g., VAS, EQ5D, DASH), x-rays, and a physical examination (Fig 1). All data and adverse events (AE) will be registered. At two years, the patient will be either seen at the outpatient clinic visit or interviewed by telephone, and the electronic patient database will be accessed to assess patient-reported outcome measures (PROMS), complications and reintervention rate.

Healing is defined as the presence of bridging bone on 3 of 4 cortices or, in cases of direct fracture healing, disappearance of the fracture line on ap and tangential x-ray views. It is assessed on follow-up x-rays 3- and 12-months after surgery. All subsequent surgical procedures during follow-up at the same site after the index operation (including hardware removal) are defined as re-interventions [11]. Complications are defined and classified according to the Clavien-Dindo-Classification of Surgical Complications [12].

All the measurements and examinations described are part of standard care, except the questionnaires. The questionnaires will be filled in at regular outpatient clinic visits or by telephone interview.