Actively Recruiting
Long vs Extended-short Nail When Treating Proximal Femur Fractures
Led by Vestre Viken Hospital Trust · Updated on 2024-05-29
800
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fractures of the upper part of the femur may be treated with intramedullary nails. There are different designs to choose from. The intention of this RCT is to compare two nails with some of the same properties, but with different lengths. Usually, it is the surgeon who decides which nail to be used. The literature indicates that there is a lack of good evidence in the decision-making, and that the choice often depends on personal preferences and experience of the surgeon. Therefore, the investigators want to compare whether one of the nails has a better outcome than the other, and in that way be able to give some clearer guidelines for treatment. Patients will be randomized into two groups, one receiving a long nail and one receiving an extended-short nail and compare surgical and functional outcomes. Information from the operation and subsequent check-ups will be analysed. The hypothesis is that the extended-short nail can reduce operating time, bleeding, fluoroscopy time and give equal or better functional outcome, without increasing reoperation rates or mortality.
CONDITIONS
Official Title
Long vs Extended-short Nail When Treating Proximal Femur Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intertrochanteric, pertrochanteric or subtrochanteric fractures
- Distal fracture limit within 4 cm below the trochanter minor
- Intramedullary nailing with TFNA-nail is indicated
- Patient is fit for surgery.
You will not qualify if you...
- AO 31-A3 fractures (revers oblique fractures)
- Cognitively impaired patients who cannot understand study information and give informed consent, and who do not have a next of kin or legal guardian to consent for them.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Drammen Hospital, Vestre Viken HF
Drammen, Norway, 3004
Actively Recruiting
2
Kongsberg hospital, Vestre Viken HF
Kongsberg, Norway, 3612
Actively Recruiting
Research Team
H
Heidi B Dyrop, MD, PHD
CONTACT
A
Andreas Stangeby, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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