Randomised controlled trial comparing the LFN (Lateral Femoral Nail) to the UFN (Unreamed Femoral Nail) in the treatment of femoral shaft fractures.

The LFN (lateral femoral nail) is a new, helical shaped implant used for the
treatment of femoral shaft fractures. The point of entry of the LFN is located
lateral to the tip of the greater trochanter. In comparison to the conventional
reamed/unreamed straight femoral nail, that has its entry point in the
piriformic fossa, the entry point of the LFN can be more easily located and it
is expected this new implant will lead to less soft tissue damage.

1 Confirm comparable results in reduction and consolidation of the fracture
fragments using the LFN vs the UFN

2 Identifying a significant difference in the soft tissue damage between the
LFN and the UFN

Prospective randomised controlled trial
Inclusion of patients will be performed at the moment there is an indication
for an intramedullary femoral nail.
Patients will be randomised into two groups.
50 patients will undergo surgery receiving the LFN, 50 patients will be treated
with the UFN.
There will be a follow-up period of 1 year with visits at 6 weeks, 3 months, 6
months and 1 year. These visits will all fall within the standard follow-up
after this kind of fracture.

Extra investigations necessary for this research:
-Clinical CT scan for measuring rotational deformities
-Abduction force measurements performed by the fysiotherapist using Biodex (4
times)
-Needle EMG after 6 weeks measuring function of the superior gluteal nerve. The
EMG will be repeated after 1 year if the first measurement is abnormal
-Filling out a questionnaire during the outclinic visits at 6 weeks, 3 months,
6 months and 1 year

Implantation of the LFN (lateral femoral nail)

The EMG is the main extra burden for the patients because it is an
uncomfortable investigation performed with a needle. However this investigation
is essential for this research to be able come to an signifcant conclusion.

The risk associated with participation is only small. The helical shape of the
new implant could cause rotational deformity of the fracture and iatrogenic
fractures. At this moment a prospective multicentre case-series study is being
performed on the LFN. 182 patients are included so far with untill now 6
iatrogenic fractuers and 2 malrotations (www.aofoundation.org)