Back to results

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)

Primary Purpose

Unstable Proximal Femoral Fracture

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

PFN-A

About this trial

This is an interventional treatment trial for Unstable Proximal Femoral Fracture focused on measuring Hip fracture, Unstable (31A2 and 31A3), Proximal femoral nail

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Universitario Parc Taulí de Sabadell

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard PFN-A

Long PFN-A

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02038686

First Posted

January 15, 2014

Last Updated

February 1, 2017

Sponsor

Ferran Fillat Gomà

Collaborators

Parc Taulí Hospital Universitari

1. Study Identification

Unique Protocol Identification Number

NCT02038686

Brief Title

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.

Acronym

PFN-A

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ferran Fillat Gomà

Collaborators

Parc Taulí Hospital Universitari

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unstable Proximal Femoral Fracture

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard PFN-A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Long PFN-A

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

PFN-A

Other Intervention Name(s)

Proximal femoral nail Synthes

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

One year

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ferran Fillat-Gomà, MD

Organizational Affiliation

Hospital Universitario Parc Tauli de Sabadell

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joan Murias-Álvarez, MD

Organizational Affiliation

Hospital Universitario Parc Tauli de Sabadell

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitario Parc Taulí de Sabadell

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs