Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

Abstract

BackgroundThe traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries.AimA prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation.Methods/designA total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses.DiscussionThis trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures.Trial registrationNetherlands National Trial Register NTR2399

Preferences of orthopedic surgeons for treating midshaft clavicle fracture in adults

“…( 7 ) Today, however, many researchers recommend surgical treatment for clavicle fractures, leading to better functional results, less pain after surgery, and early return to labor/sports activities. ( 12 , 24 , 25 ) Nonetheless, the choice of treatment is not only limited by fracture characteristics, but also by expectations of treatment benefits, perceptions on risk factors for pseudarthrosis with conservative treatment, as well as by potential complications of surgical interventions. Furthermore, some variables, such as activity level and time to return to daily activities, should be considered when selecting treatment.…”

“…Currently, some of the indications for operative treatment include exposed fractures, neurovascular involvement, skin involvement, displacement of bone fragments, initial shortening greater than 20mm, severe comminution, floating shoulder, and vicious consolidation/pseudarthrosis. ( 12 ) The most commonly used operative approaches are open reduction and internal fixation with flexible plates or rods. ( 13 )…”

Clinical outcome and radiographic change of ipsilateral scapular neck and clavicular shaft fracture: comparison of operation and conservative treatment

“…Inclusion criteria were age between 20 and 70 years and displaced ipsilateral clavicular shaft and scapular neck fractures. The definition of displacement of clavicular facture was 1) displacement greater than 10 mm or 2) shortening greater than 20 mm [ 10 ]. Displacement of scapular neck fracture was defined as 1) displacement greater than 20 mm, 2) angulation greater than 40°, or 3) the combination of angulation greater than 30° and displacement greater than 15 mm [ 11 ].…”

Passform eines neuen auf Basis einer anatomischen Knochendatenbank entwickelten Klavikula-Osteosyntheseplattensystems (VariAx Clavicle) im Vergleich zu individuell von Chirurgen gebogenen Rekonstruktionsplatten

“…Im Rahmen der weiteren wissenschaftlichen Analyse müssen Faktoren wie Pseudarthroserate, funktionelle Ergebnisse, Schmerz-Scores, Lebensqualität und kosmetische Aspekte berücksichtigt werden [23]. In der Vergangenheit hat sich bei anatomisch vorgeformten Implantaten im Bereich der Tibia eine hohe Passungenauigkeit gezeigt [5,18].…”