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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. (PFN-A)

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ClinicalTrials.gov Identifier: NCT02038686
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Hospital Parc Taulí, Sabadell
Information provided by (Responsible Party):
Ferran Fillat Gomà, Corporacion Parc Tauli

Brief Summary:
  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.

Condition or disease Intervention/treatment Phase
Unstable Proximal Femoral Fracture Device: PFN-A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
Device: PFN-A
Other Name: Proximal femoral nail Synthes
Active Comparator: Long PFN-A
Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)
Device: PFN-A
Other Name: Proximal femoral nail Synthes



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038686


Locations
Spain
Hospital Universitario Parc Taulí de Sabadell
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Ferran Fillat Gomà
Hospital Parc Taulí, Sabadell
Investigators
Principal Investigator: Ferran Fillat-Gomà, MD Hospital Universitario Parc Tauli de Sabadell
Study Director: Joan Murias-Álvarez, MD Hospital Universitario Parc Tauli de Sabadell

Responsible Party: Ferran Fillat Gomà, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02038686     History of Changes
Other Study ID Numbers: CSPTCOT2013/01
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017

Keywords provided by Ferran Fillat Gomà, Corporacion Parc Tauli:
Hip fracture
Unstable (31A2 and 31A3)
Proximal femoral nail

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries