Background and aims
Collarbone (middle third clavicle) fractures are a common injury and account for up to 4% of all fractures. Although the majority of acute (recent injury) fractures can be treated conservatively, for instance by using a sling, there are some types of fracture that need to be surgically treated. Non-union of the collarbone, which results from failed fracture healing, is usually treated surgically when a person has pain and difficulties in using their shoulder.
This review set out to evaluate the effects, primarily on pain and long-term function, of different methods for surgically treating collarbone fractures and non-union.
We searched the scientific literature up to 27 June 2014 and found seven relevant studies with 398 participants. The seven small studies had methodological limitations that may affect the reliability of their findings. The types of surgical fixation evaluated were dynamic compression plates, low-contact dynamic compression plates, and intramedullary nails. Dynamic compression plates are screwed to the collarbone and apply pressure between the fractured ends; low-contact dynamic compression plates are similar, but are designed to have less contact with the underlying bone. Some compression plates can be customised to the three-dimensional contours of the bone before application. Unlike a compression plate, which is fixed to the external surface of the collarbone, an intramedullary nail is inserted into the bone's internal 'cavity' to span and stabilise the fracture.
Four poor quality studies compared intramedullary fixation with plate fixation in 160 people with acute collarbone fractures. Pooled data from three studies did not show a clinically important difference between the two types of surgery in upper arm function at long term follow-up of six months or more. The studies found little difference between intramedullary fixation and plate fixation in pain, treatment failure resulting in non-routine surgery or in time to fracture healing (three trials). Pooled data from all four studies indicated that fewer people had adverse events, such as infection or prominent or troublesome hardware, after intramedullary fixation but the converse result where fewer people had adverse events after plate fixation could not be ruled out.
One poor quality trial that involved 36 participants compared two types of plates for treating non-union of fractures of the middle third of the collarbone. The trial found that participants treated with a low-contact dynamic compression plate reported better upper arm function during the year after surgery and returned to work earlier than those people treated with a standard dynamic compression plate. The second trial, which was also of poor quality, concluded that there were advantages in using intramedullary nail fixation compared with plate fixation in 69 people with either acute fractures or non-union. The third trial, involving 133 participants, was well conducted but did not include enough participants to be conclusive. It compared two different techniques for placement of plates to fix displaced collarbone fractures. This trial found that a technique in which the plate was contoured in three dimensions before fixation to the collarbone gave better results than placing the plate along the upper surface of the collarbone.
Conclusions and quality of evidence
We judged the evidence for all four comparisons was low or very low quality because the studies were at risk of bias due to flawed methods and the data too few to be sure that the results were not due to chance. This means that we are unsure that the results gave a true picture of the clinically important differences between the methods of surgery under comparison. Hence, we conclude that the evidence regarding the effectiveness of different methods of surgical interventions for treating fracture and non-union of the collarbone is very limited and that further studies are justified.
There is very limited and low quality evidence available from randomised controlled trials regarding the effectiveness of different methods of surgical fixation of fractures and non-union of the middle third of the clavicle. The evidence from four ongoing trials is likely to inform practice for the comparisons of intramedullary versus plate fixation and anterior versus superior plates for acute fractures in a future update. Further randomised trials are warranted, but in order to optimise research effort, these should be preceded by research that aims to identify priority questions.
This review covers two conditions: acute clavicle fractures and non-union resulting from failed fracture healing. Clavicle (collarbone) fractures account for around 4% of all fractures. While treatment for these fractures is usually non-surgical, some types of clavicular fractures, as well as non-union of the middle third of the clavicle, are often treated surgically. This is an update of a Cochrane review first published in 2009.
To evaluate the effects (benefits and harms) of different methods of surgical treatment for acute fracture or non-union of the middle third of the clavicle.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (27 June 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 5), MEDLINE (1966 to June week 3 2014), EMBASE (1988 to 2014 week 25), LILACS (1982 to 27 June 2014), trial registries and reference lists of articles. We applied no language or publication restrictions.
We considered randomised and quasi-randomised controlled trials evaluating any surgical intervention for treating people with fractures or non-union of the middle third of the clavicle. The primary outcomes were shoulder function or disability, pain and treatment failure (measured by the number of participants who had undergone or were being considered for a non-routine secondary surgical intervention for symptomatic non-union, malunion or other complications).
Two review authors selected eligible trials, independently assessed risk of bias and cross-checked data. Where appropriate, we pooled results of comparable trials.
We included seven trials in this review with 398 participants. Four trials were new in this update.
The four new trials (160 participants) compared intramedullary fixation with open reduction and internal fixation with plate for treating acute middle third clavicle fractures in adults. Low quality evidence from the four trials indicated that intramedullary fixation did not result in a clinically important improvement in upper arm function (despite a statistically significant difference in its favour: standardised mean difference 0.45, 95% confidence interval (CI) 0.08 to 0.81; 120 participants, three trials) at long term follow-up of six months or more. Very low quality evidence indicated little difference between intramedullary fixation and plate fixation in pain (one trial), treatment failure resulting in non-routine surgery (2/68 with intramedullary fixation vs. 3/65 with plate fixation; risk ratio 0.69, 95% CI 0.16 to 2.97, four trials) or time to clinical fracture consolidation (three trials). There was very low quality evidence of a lower incidence of participants with adverse events (mainly infection, poor cosmetic result and symptomatic hardware) in the intramedullary fixation group (18/68 with intramedullary fixation vs. 27/65 with plate fixation; RR 0.64, 95% CI 0.39 to 1.03) but the CI of the pooled results also included the small possibility of a lower incidence in the plate fixation group. None of the four trials reported on quality of life or return to previous activities. Evidence is pending from two ongoing trials, with planned recruitment of 245 participants, testing this comparison.
There was low or very low quality evidence from three small trials, each testing a different comparison. The three trials had design features that carried a high risk of bias, potentially limiting the reliability of their findings. Low-contact dynamic compression plates appeared to be associated with significantly better upper-limb function throughout the year following surgery, earlier fracture union and return to work, and a reduced incidence of implant-associated symptoms when compared with a standard dynamic compression plate in 36 adults with symptomatic non-union of the middle third of the clavicle. One quasi-randomised trial (69 participants) compared Knowles pin versus a plate for treating middle third clavicle fractures or non-union. Knowles pins appeared to be associated with lower pain levels and use of postoperative analgesics and a reduced incidence of implant-associated symptoms. One study (133 participants) found that a three-dimensional technique for fixation with a reconstruction plate was associated with a significantly lower incidence of symptomatic delayed union than a standard superior position surgical approach. Evidence is pending from two ongoing trials, with planned recruitment of 130 participants, comparing anterior versus superior plates for acute fractures.