Plate fixation compared with nonoperative treatment of displaced midshaft clavicular fractures: a randomized clinical trial

Abstract

AimsRecent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.Patients and MethodsIn a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year.ResultsA total of 60 patients in the nonoperative group and 64 in the operative group completed one-year follow-up. At three months’ follow-up, both the median DASH (1.7 vs 8.3) and median Constant scores (97 vs 90) were significantly better in the operated group (both p = 0.02). After six months and one year, there was no difference in the median DASH or Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients, p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The plate was subsequently removed in 16 patients (25%). One patient had a new fracture after removal of the plate and one underwent revision surgery for failure of fixation.ConclusionFixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking screws results in faster functional recovery and a higher rate of union compared with nonoperative management, but the function of the shoulder is equal after six months and at one year. Cite this article: Bone Joint J 2018;100-B:1385–91.

Operative treatment of displaced midshaft clavicular fractures is not cost-effective

“…7,8 The decision model was constructed on the basis of a Danish RCT comparing operative and nonoperative treatment. 23 From the Danish RCT, we retrieved data on patient utility, hospitalization, and productivity costs. In addition, the decision model was supplemented with the best available evidence from the literature to represent the pathways patients can follow, after receiving a specific treatment regimen.…”

“…The probability of hospitalization after operative treatment was drawn from a recent Danish RCT. 23 The probabilities of the following outcomes were estimated based on a meta-analysis of data from existing RCTs (Table I): nonunion, accepting an operation after development of a nonunion, plate removal, and deep infection. 4,12,13,25,33,35 The RCTs were identified through a systematic literature search performed during spring 2017 (a similar protocol was described by Woltz et al 34 ).…”

“…All costs were estimated in Danish currency (Danish krone [kr]) based on 2016 prices and subsequently converted to Euros (V) (with an exchange rate of V100 ¼ kr746). For the health-sector perspective, all direct and indirect relevant health care-related costs at the hospital, 23,30 as well as health care-related costs regarding recommended follow-up visits with the general practitioner, 21 were included (Table II). In addition, some costs fall outside the budget of the Danish health care system, for example, transportation, 17 pharmaceuticals, 29 and productivity costs, 5,23 and these were included in the societal perspective (Table III).…”

“…For the health-sector perspective, all direct and indirect relevant health care-related costs at the hospital, 23,30 as well as health care-related costs regarding recommended follow-up visits with the general practitioner, 21 were included (Table II). In addition, some costs fall outside the budget of the Danish health care system, for example, transportation, 17 pharmaceuticals, 29 and productivity costs, 5,23 and these were included in the societal perspective (Table III). Productivity costs were estimated by using the human capital approach and the number of sick days for patients in both treatment groups reported in a Danish RCT.…”

“…Productivity costs were estimated by using the human capital approach and the number of sick days for patients in both treatment groups reported in a Danish RCT. 7,23 The number of sick days was multiplied by an average gross wage for Danish citizens 5 adjusted for workforce frequency and employment rates for the population included in the Danish RCT. 23 Furthermore, statistical adjustments were made for age, sex, self-reported high-load shoulder professions, and whether the dominant side (left or right) was fractured.…”