Clinical trial NCT04652310: Long vs Extended-short Nail When Treating Proximal Femur Fractures
Official title: Long vs Extended-short Nail When Treating Proximal Femur Fractures - An RCT-study Examining Differences in Functional and Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Keywords: intramedullary nailing
TFNA
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background Intramedullary nails have in recent years become the preferred technique compared to DHS when treating proximal femur fractures. A Norwegian RCT has showed the same frequency of postoperative pain, functional outcome and rate of reoperations comparing the two techniques. Nails are usually provided in a long and short model. Deciding which nail length to use is highly discussed, and often a long nail is preferred, because it gives a theoretically more stable and secure fixation of the femur. There are, however many advantages of using a short nail. It is less time consuming as there is no need for reaming, securing the long nail distally requires more fluoroscopy time, and distal locking of the long nail has also been shown to increase the risk of perioperative fractures. Perioperative bleeding and postoperative blood transfusions are reduced when using a short nail, and a long nail may also give more pain distally around the thigh and around the knee owing to cortical impingement. Finally, the long nail is more expensive compared to short models. There is a perception in the orthopedic society that there's a higher risk of periprosthetic fractures with short nails, but the latest generations of nails have improved this problem. Most studies report no difference in periprostetic fractures between long and short nails. Recently, new extended-short versions of medullary nails are being produced. The extended-short nail combines the mechanical properties seen in a long nail and the surgical simplicity of a short nail. This new nail type may replace the use of several long nails being placed just to be on the safe side, and thus reduce operating time, bleeding and postoperative pain associated with a long nail. Biomechanical studies have showed that the mechanical properties of long and extended-short nails are predominantly comparable, but to our knowledge no clinical studies comparing the extended-short and long nails have been performed to date. The advantages of an extended-short nail are potentially great, which makes it important to clarify which opportunities there are to benefit from this type of nail for certain types of fractures, both in the interest of the patient as well as the economic healthcare perspective.

Purpose In a well-defined population of patients with proximal femur fractures within a certain anatomical area the aim is to compare the extended-short nail with the long nail, to evaluate differences in functional and surgical outcome.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* AO 31-A3 fractures (revers oblique fractures)
* Cognitively impaired patients who themselves cannot understand the study information and give informed consent, and do not have a next of kin or legal guardian who can give consent on their behalf.

Primary outcomes:
measure: Difference in Short Physical Performance Battery (SPPB)-score
timeFrame: At 3 months and 1 year
Secondary outcomes:
measure: Difference in Operation time
timeFrame: Surgery date
measure: Difference in Blood loss
timeFrame: Surgery date
measure: Difference in Harris Hip score
timeFrame: 3 months and 1 year
measure: Difference in EQ5D-5L (EuroQoL 5L - health-related quality of life)
timeFrame: 3 months and 1 year
measure: Difference in Transfusion after surgery
timeFrame: 2 weeks after surgery
measure: Difference in Fluoroscopy time
timeFrame: Surgery date
measure: Difference in Postoperative complications
timeFrame: Minimally 1 year
measure: Difference in Mortality
timeFrame: Minimally 1 year
measure: Difference in Reoperations
timeFrame: Minimally 1 year
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital, Vestre Viken HF
city: Kongsberg
country: Norway
facility: Kongsberg hospital, Vestre Viken HF
Study officials:
affiliation: Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF
name: Heidi B Dyrop, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: