Long vs Extended-short Nail When Treating Proximal Femur Fractures

Long vs Extended-short Nail When Treating Proximal Femur Fractures - An RCT-study Examining Differences in Functional and Surgical Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Device: TFNA extended-short nail (235 mm); Device: TFNA long nail (260-480mm)

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.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi B Dyrop, MD, PHD; Phone Number: +4799030104; Email: heidyr@vestreviken.no
• Study Contact Backup: Name: Andreas Stangeby, MD; Phone Number: +4793457441; Email: antsta@vestreviken.no

Study Locations

• Norway
  • Drammen, Norway, 3004
    • Recruiting
    • Drammen Hospital, Vestre Viken HF
    • Contact: Magnus Talen, MD; Email: magtal@vestreviken.no
    • Contact: Lukas Månsson, MD; Email: Lukas.Mansson@vestreviken.no
  • Kongsberg, Norway, 3612
    • Recruiting
    • Kongsberg hospital, Vestre Viken HF
    • Contact: Heidi B Dyrop, MD, PHD; Phone Number: +4799030104; Email: heidyr@vestreviken.no
    • Contact: Andreas Stangeby, MD; Phone Number: +4793457441; Email: antsta@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extended-Short Nail; Implantation of TFNA extended-short nail (235 mm)	Device: TFNA extended-short nail (235 mm); The extended short version of the TFN-advanced proximal femoral nailing system (TFNA); Other Names: TFN-advanced proximal femoral nailing system (TFNA) 235 mm
Active Comparator: Long nail; Implantation of TFNA long nail (260-480 mm)	Device: TFNA long nail (260-480mm); The long version of the TFN-advanced proximal femoral nailing system (TFNA); Other Names: TFN-advanced proximal femoral nailing system (TFNA) 260-480mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Short Physical Performance Battery (SPPB)-score	Short Physical Performance Battery (SPPB)-score, ranges from 0-12, 12 is the best indicating a good physical function.	At 3 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Operation time	Operation time in minutes	Surgery date
Difference in Blood loss	Blood loss during surgery	Surgery date
Difference in Harris Hip score	Harris Hip score, ranges from 0-100, 100 is the best score, a high score indicates good physical function.	3 months and 1 year
Difference in EQ5D-5L (EuroQoL 5L - health-related quality of life)	EQ5D-5L (EuroQoL 5L - health-related quality of life)measures health status terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using three-level (EQ-5D-3L) or five-level (EQ-5D-5L) scale	3 months and 1 year
Difference in Transfusion after surgery	Need for transfusion of blood products after surgery	2 weeks after surgery
Difference in Fluoroscopy time	Fluoroscopy time during surgery	Surgery date
Difference in Postoperative complications	Any postoperative complications	Minimally 1 year
Difference in Mortality	Mortality after surgery	Minimally 1 year
Difference in Reoperations	Reoperations of any kind	Minimally 1 year

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Investigators: Principal Investigator: Heidi B Dyrop, MD, PHD, Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: intramedullary nailing; TFNA
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: REK 2019/125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No