Clinical trial 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unstable Proximal Femoral Fracture
Keywords: Hip fracture
Unstable (31A2 and 31A3)
Proximal femoral nail
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Parc Taulí Hospital Universitari
First posted: 2014-01-16
Enrollment: 188
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total number of complications between PFN-A short and PFN-A long
timeFrame: One year
Secondary outcomes:
measure: Complete and uneventful radiological and clinical healing of the fracture and mortality
timeFrame: One year
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Taulí de Sabadell
state: Barcelona
Study officials:
affiliation: Hospital Universitario Parc Tauli de Sabadell
name: Ferran Fillat-Gomà, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Parc Tauli de Sabadell
name: Joan Murias-Álvarez, MD
role: STUDY_DIRECTOR
References: