Long vs Extended-short Nail When Treating Proximal Femur Fractures

NCT ID: NCT04652310

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2025-12-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Extended-Short Nail

Implantation of TFNA extended-short nail (235 mm)

Group Type: ACTIVE_COMPARATOR

TFNA extended-short nail (235 mm)

Intervention Type: DEVICE

The extended short version of the TFN-advanced proximal femoral nailing system (TFNA)

Long nail

Implantation of TFNA long nail (260-480 mm)

Group Type: ACTIVE_COMPARATOR

TFNA long nail (260-480mm)

Intervention Type: DEVICE

The long version of the TFN-advanced proximal femoral nailing system (TFNA)

Interventions

TFNA extended-short nail (235 mm)

The extended short version of the TFN-advanced proximal femoral nailing system (TFNA)

Intervention Type: DEVICE

TFNA long nail (260-480mm)

The long version of the TFN-advanced proximal femoral nailing system (TFNA)

Intervention Type: DEVICE

Other Intervention Names

TFN-advanced proximal femoral nailing system (TFNA) 235 mm; TFN-advanced proximal femoral nailing system (TFNA) 260-480mm

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi B Dyrop, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF

Locations

Drammen Hospital, Vestre Viken HF

Drammen, , Norway

Site Status: RECRUITING

Kongsberg hospital, Vestre Viken HF

Kongsberg, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Heidi B Dyrop, MD, PHD

Role: CONTACT

heidyr@vestreviken.no

+4799030104

Andreas Stangeby, MD

Role: CONTACT

antsta@vestreviken.no

+4793457441

Facility Contacts

Magnus Talen, MD

Role: primary

magtal@vestreviken.no

Lukas Månsson, MD

Role: backup

Lukas.Mansson@vestreviken.no

Heidi B Dyrop, MD, PHD

Role: primary

heidyr@vestreviken.no

+4799030104

Andreas Stangeby, MD

Role: backup

antsta@vestreviken.no

+4793457441

Other Identifiers

REK 2019/125

Identifier Type: -

Identifier Source: org_study_id