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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02038686

Acronym

PFN-A

Enrollment

188

Registered

2014-01-16

Start date

2014-01-31

Completion date

2017-01-31

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unstable Proximal Femoral Fracture

Keywords

Hip fracture, Unstable (31A2 and 31A3), Proximal femoral nail

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.

Interventions

DEVICEPFN-A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Total number of complications between PFN-A short and PFN-A long	One year	follow-up data is recruited at 4 weeks, 3 months and one

Secondary

Measure	Time frame	Description
Complete and uneventful radiological and clinical healing of the fracture and mortality	One year	follow-up data is recruited at 4 weeks, 3 months and one year.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026