Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01015924 |
| Other study ID # |
rek 1.2009.1196 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
November 17, 2009 |
| Last updated |
January 30, 2014 |
| Start date |
July 2009 |
| Est. completion date |
September 2013 |
Study information
| Verified date |
January 2014 |
| Source |
University Hospital, Akershus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Norway: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare two widely used operative techniques on displaced
midshaft clavicular fractures. The hypothesis is that there is no difference in functional
outcome.
Description:
Clavicular fracture is one of the most common fractures, accounting for about 4 % of all
fractures. Midshaft fractures account for approximately 80%. Traditionally, midshaft
fractures have been thought to have a good prognosis even when substantially displaced, and
most have been treated nonoperatively with a sling or a figure of eight bandage. Early
studies by Neer and Rowe in the 60´s demonstrated a very low non-union rate, with av
prevalence of 4 in a series of 566 patients, and 3 nonunions in 2235 in another. On this
basis, the general view has been that the vast majority of even severely displaced midshaft
fractures healed uneventfully, with a very low nonunion rate and a good functional result.
Operative results reported on the other hand bad results, especially concerning the risk of
infection. Recent studies, however, conclude differently, and suggest the outcomes of
displaced fractures might not be as favourable as once thought. Hill showed in a series of
52 completely displaced midclavicular fractures a nonunion rate of 15% (8 of 52 patients)
and 31% (16 of 52) of patients were not satisfied with the end result. This correlated with
a shortening of more than 2 cm. In a prospective study of 222 patients by Nowak, 42% (93 of
222) were found to have persisting symptoms after 6 months wheras 15% were found to have
nonunion. These symptoms seem to persist even after 9 - 10 years reporting 29 % of 208
patients having pain during activity and 9% pain at rest. 46% did not consider themselves
fully recovered.
Similar result were found in a systemic review of 2144 fractures. 15.1 % (24 of 159) of
nonoperative treated dislocated fractures resulted in nonuion, whereas 2,2% (10 of 460) and
2% (5 of 152) nonunions were found in fractures treated operatively with either plate or
intramedullary pins. On this basis, it is becoming more evident that conservative treatment
gives much inferior results compared to earlier reported results.
The operative approach to midclavicular fractures have traditionally been plate
osteosynthesis or intramedullary nailing. Poigenfürst in 1992 showed in a series of 122
patients a low nonunion rate and good functional results after plating. Likewise,
intramedullary nailing has been described as an alternative technique with good results.
Kettler demonstrated en a series of 87 patients a good functional results union in 97,7 % (
85 of 87) and no infections. Similar results were fond by Rehm in 2004, with one nonunion of
136 fractures treated and a constant score one year after implant removal of 97.
Operative treatment of displaced midclavicular fracture thus shows reliable good results
compared to earlier reported results. In 2007, the Canadian Orthopedic Trauma Society
published a prospective randomised controlled trial of 132 patients, randomised to either
conservative treatment with a sling, or plate fixation. The operative group showed clear
superiority in Constant and DASH scores, reduction in risk of developing non-union, earlier
return to work. With intramedullary nailing using ESIN technique, Smekal et al demonstrated
superior results in the operative group in a prospective randomised controlled trial of 60
patients. 30 patients were opereated with elastic stable intramedullary nailing, and 30
patients were randomised to conservative treatment with a sling. The operative group had
fewer complications, shorter time to union and a better functional outcome.
It seems from the above, that it is reasonable to offer operative treatment to active adults
with displaced fractures of the middle third of the clavicle due to the risk of developing a
symptomatic non- or malunion. Both plate fixation and intramedullary nailing of displaced
fractures are described as safe methods of operative treatment. To our knowledge, there has
never been conducted a prospective randomised controlled trial that compares different forms
of the former mentioned operative alternatives.
On this basis, we plan to contuct a prospective randomised controlled trial comparing
operative plate fixation and intramedullary nailing with TEN.
