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Completed

NCT Number: NCT03000972

PFN-A Augmentation for Intertrochanteric Femoral Fractures

This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

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Key information

Conditions

Intertrochanteric Fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital

Uppsala, Uppsala County, 75185, Sweden

About this study

Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.

The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
  • Healthy contralateral hip
  • ASA (American Society of Anesthesiologists) Physical Status Class I or II

Exclusion criteria

  • Dementia

Treatment and study plan

Cement augmentation

Procedure

PFN-A Nail

Procedure

Primary outcomes

  1. Viability of the femoral head as assessed by fluoride uptake using PET-CT

    Time frame: 4 months postoperatively

    The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.

Secondary outcomes

  1. Viability of the femoral head as assessed by fluoride uptake using PET-CT

    Time frame: Within 1 week postoperatively

  2. Viability of the femoral head as assessed by fluoride uptake using PET-CT

    Time frame: 1 year postoperatively

  3. Harris Hip Score

    Time frame: 4 months

  4. Harris Hip Score

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2016
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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