Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate?
Condition: Acute, Displaced Midshaft Clavicle Fractures
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures
      seen in orthopedics.

      There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle
      fractures. Conservative treatment has, traditionally, been the preferred treatment but recent
      studies have shown higher incidences of non-union and symptomatic malunion associated with
      conservative treatment. Primary surgery has in several studies been associated with high
      success rates and few complications but there is no compelling evidence towards superior
      results after primary surgery.

      The objective of this randomized study is to compare conservative treatment (sling) with
      primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.
    

Detailed description: 
      Conservative treatment has been the preferred treatment for midshaft clavicle fractures,
      whether the fracture is displaced or undisplaced. The background for this comes from two
      large studies done in the 60s. C. Neer (2235 patients) and C. R Rowe (566 patients) showed
      respectively in 1960 and 1968 that patients with a clavicle fracture, even with larger
      fracture displacements, had few symptoms when the fracture is healed and that the incidence
      of non-union is below 1%. Both studies have been criticized for including children and
      adolescents where the healing potential is significantly larger than in adults and that their
      results are based purely on surgical and radiologic endpoints and no patient-reported outcome
      measurements were used.

      Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures
      seen in orthopedics. The incidence of clavicle fracture is somewhere between 29 and 64 per
      100000 per year. Fracture of the clavicle most frequently occurs in young men and the
      male-to-female distribution is 2.6:1. Between 70 and 80% of all clavicle fractures are
      localized to the middle part of the clavicle and of these, most fractures are displaced.
      Midshaft clavicle fracture is defined as a fracture in the middle 3/5 parts of the clavicle
      (lateral boundary is a vertical line from the base of processus coracoideus and medial border
      is a vertical line from the middle of the first rib).

      Recent studies have shown higher incidences of non-union, especially when the fracture is
      displaced and a shortening of two cm or more occurs. Malunion, that was previously not
      considered clinically important, appears in several resent studies to be associated with
      profound symptomatic shoulder problems. One study reported that up to 30% of the displaced
      clavicle fractures that healed with malunion results in profound symptoms and discomfort of
      the shoulder.

      Surgery, with plate osteosynthesis of the displaced clavicle fracture, has in several studies
      been associated with a high success rate and few complications. To date only one randomized
      trial comparing conservative treatment with plate osteosynthesis of the displaced midshaft
      fracture has been done. This Canadian multi-center study from 2007, where 132 patients were
      randomized (111 patients completing), concludes that there is a small significant improvement
      in functional outcome in patients where the fracture has been osteosynthesised compared with
      conservative treatment. This study recommends surgery of displaced fractures in active
      patients.

      Recently two review articles have questioned the results from the Canadian study because it
      is unclear whether the poorer functional outcome in the conservatively treated group is due
      to the non-unions in this group (14.2%). They both conclude that there is an estimated risk
      of overtreatment as a numbers-needed-to-treat analysis estimates the 9 operations is needed
      to prevent 1 non-union.

      Though the evidence for surgical intervention over conservative treatment for displaced
      midshaft clavicle fractures still is controversial it seems that more and more patients are
      treated with primary operative intervention.

      Because of this tendency there is a need to validate whether operative intervention with a
      clavicle plate is superior or not compared to the conservative treatment for displaced
      midshaft clavicle fractures.
    

Intervention name(s): Conservative Treatment; Surgical treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Simple Sling; Superior Locking plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clavicle fractures; midshaft clavicle fractures; conservative treatment; surgical treatment; functional outcome; clinical assessment; adults