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.

NCT02038686 | Completed DMC

• 1 other identifier: CSPTCOT2013/01
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Introduction:
2. 2.Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer complications than Long PFN-A
3. 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.

Conditions

Unstable Proximal Femoral Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total number of complications between PFN-A short and PFN-A long

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

  One year

Secondary Outcomes (1)

• Complete and uneventful radiological and clinical healing of the fracture and mortality

  One year

Study Arms (2)

Standard PFN-A

ACTIVE COMPARATOR

Patients with unstable proximal femoral fractures treated with PFN-A short nail (170-240mm)

Device: PFN-A

Long PFN-A

ACTIVE COMPARATOR

Patients with unstable proximal femoral fractures treated with PFN-A long nail (300-420mm)

Device: PFN-A

Interventions

PFN-A DEVICE

Also known as: Proximal femoral nail Synthes

Long PFN-A; Standard PFN-A

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferran Fillat Gomà: lead
• Parc Taulí Hospital Universitari: collaborator

Study Sites (1)

Hospital Universitario Parc Taulí de Sabadell

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Ferran Fillat-Gomà, MD

  Hospital Universitario Parc Tauli de Sabadell

  PRINCIPAL INVESTIGATOR

• Joan Murias-Álvarez, MD

  Hospital Universitario Parc Tauli de Sabadell

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

ES (1)