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OpenTrials
Completed

NCT Number: NCT02038686

Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractures. Randomised Comparison of the Proximal Femoral Nail PFN-A Short and the PFN-A Long.

1. Introduction:

Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial is performed to compare the outcome treatment of these unstable fractures of the proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A (300-420mm). 2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A

Main Objective: Is defined as Total number of complications between PFN-A short and PFN-A long. Outcome measures were subdivided into preoperative, perioperative and post-operative. Follow up data at four weeks, three months and one year.

Secondary objectives: Complete and uneventful radiological and clinical healing of the fracture. Revision operations (related to the failure of primary treatment) and mortality. Baseline characteristics were documented pre-operatively: Outcome measures were subdivided into intra-operative, post-operative and follow up data at four weeks, three months and one year. 3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and 31-A3 fracture of the proximal part of the femur will be randomized, at the time of the admission, to fixation with use either a short PFN-A or a long PFN-A.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Parc Taulí de Sabadell

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 60 years old above.
  • Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones
  • Patients that accept to participate on the study under consent

Exclusion criteria

  • Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application.
  • Combination of fractures in the proximal femur.
  • Pathological fractures.
  • Diaphyseal femoral fractures.
  • Rejection of surgery by the patient.
  • Contraindications to the use of either implants studied.
  • Patients who do not wish to participate in this study

Treatment and study plan

PFN-A

Device

Other names: Proximal femoral nail Synthes

Primary outcomes

  1. Total number of complications between PFN-A short and PFN-A long

    Time frame: One year

    follow-up data is recruited at 4 weeks, 3 months and one

Secondary outcomes

  1. Complete and uneventful radiological and clinical healing of the fracture and mortality

    Time frame: One year

    follow-up data is recruited at 4 weeks, 3 months and one year.

Sponsors and collaborators

Lead sponsor

Ferran Fillat Gomà

Other

Collaborators

  • Parc Taulí Hospital Universitari

Registry information

Acronym: PFN-A

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 16, 2014
Registry last updated
Feb 2, 2017

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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