Treatment of Unstable 31.A2 and 31.A3 Trochanteric Fractu... | NCT02038686

Studies
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

Sponsor

Ferran Fillat Gomà

Status

Completed

Last Update Posted

Feb 2, 2017Estimated

Enrollment

188Actual

Phase

Not Applicable

Conditions

Unstable Proximal Femoral Fracture

Interventions

PFN-A

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2017Actual

First Submitted Date

Jan 15, 2014

First Submission Date that Met QC Criteria

Jan 15, 2014

First Posted Date

Jan 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2017

Last Update Posted Date

Feb 2, 2017Estimated

Name	Class
Parc Taulí Hospital Universitari	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PFN-A	Device		Long PFN-A Standard PFN-A	Proximal femoral nail Synthes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.	One year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ferran Fillat-Gomà, MD	Hospital Universitario Parc Tauli de Sabadell	Principal Investigator
Joan Murias-Álvarez, MD	Hospital Universitario Parc Tauli de Sabadell	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Parc Taulí de Sabadell		Sabadell	Barcelona	08208	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided