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Long vs Extended-short Nail When Treating Proximal Femur Fractures

NCT04652310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

  • Hip Fractures

Interventions

DEVICE

TFNA extended-short nail (235 mm)

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

DEVICE

TFNA long nail (260-480mm)

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

Sponsors & Collaborators

  • Vestre Viken Hospital Trust

    lead OTHER

Principal Investigators

  • Heidi B Dyrop, MD, PHD · Orthopedic Dpt, Kongsberg Hospital, Vestre Viken HF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2024-11-30
Completion
2025-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04652310 on ClinicalTrials.gov