ClinicalTrials.Veeva

Menu

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.

F

Ferran Fillat Gomà

Status

Completed

Conditions

Unstable Proximal Femoral Fracture

Treatments

Device: PFN-A

Study type

Interventional

Funder types

Other

Identifiers

NCT02038686
CSPTCOT2013/01

Details and patient eligibility

About

  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.

Enrollment

188 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

188 participants in 2 patient groups

Standard PFN-A
Active Comparator group
Description:
Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)
Treatment:
Device: PFN-A
Long PFN-A
Active Comparator group
Description:
Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)
Treatment:
Device: PFN-A

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems