Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652310
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-11-26
Brief Title:
Long vs Extended-short Nail When Treating Proximal Femur Fractures
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
Long vs Extended-short Nail When Treating Proximal Femur Fractures - An RCT-study Examining Differences in Functional and Surgical Outcomes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 theres 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None