Clavicle Fracture
Conditions
Keywords
Clavicle/injuries, Bone Plates, Non-Randomized Controlled Trials as Topic
Brief summary
The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is: 1\. Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?
Detailed description
Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.
Interventions
PROCEDUREClavicle plating
VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate
Sponsors
Kantonsspital Obwalden
Spital Schwyz
Stryker SA
Luzerner Kantonsspital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2) * Patients that are eligible for operative treatment of clavicle fractures. Generally accepted indications include: * Displacement of one or more shaft width * Shortening of more than 1cm in length * High demand patients (physical activity)
Exclusion criteria
* Delayed presentation (\> 14 days) * Initial operative treatment at non-participating hospitals * Open fractures * Pathological fractures * Re-fractures of clavicle * Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs) * Cognitive impairment or language barrier precluding answering questionnaires * Unable to complete follow-up (e.g. different residential area/tourists)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of surgical re-interventions | 2 years follow-up | Any type of re-intervention (i.e. plate removal, screw adjustment etc.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fracture realted infections | 2 years follow-up | According to metsemakers et al, 2018 (Metsemakers WJ, Morgenstern M, McNally et al., MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24. PMID: 28867644) |
| Symptomatic non union | 1 year follow-up | defined as absence of radiological signs of healing (callus formation or fading of fracture lines) combined with pain at the fracture site at 12 months. |
| Asymptomatic non-union | 1 year follow-up | defined as absence of radiological signs of healing (callus formation or fading of fracture lines) without any clinical symptoms. |
| Numbness below scar line | 1 year follow-up | Tested postoperatively and at 12 months follow-up |
| Self-reported implant irritation/implant prominence | 1 year follow-up | According to Hulsman et al, 2018 (17. Hulsmans M, van Heijl M, Houwert R, et al., Intramedullary nailing of displaced midshaft clavicle fractures using a TEN with end cap: issues encountered. Acta Orthop Belg. 2018 Dec;84(4):479-484. PMID: 30879453.) |
| Number of surgical re-interventions | 1 year follow-up | (including implant removal) |
| Length of surgical incision | basline | Length of surgical incision in cm |
| DASH score | baseline, 3- and 12-monts follow-up | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. |
| EQ-5D | baseline (pre-injury), 3- and 12-months follow-up | to monitor changes in self-reported health status through time in a given patient group |
| VAS pain score | 3- and 12-months follow-up | Self-reported pain on a scale of 0 to 10. |
| VAS for patient satisfaction | 3- and 12-months follow-up | Self-reported satisfaction on a scale of 0 to 10 |
| Operative time | Baseline | — |
Contacts
Primary ContactFrank Beeres, PhD/M.D.
Backup ContactBryan van de Wall, PhD/M.D.
Outcome results
None listed