Proximal Femur Locking Compression Plates Versus Trochanteric Nails

NCT ID: NCT01128868

Last Updated: 2020-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.

"Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith \& Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).

Detailed Description

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Conditions

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Reverse Oblique Intertrochanteric Fractures Reverse Oblique Subtrochanteric Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proximal femur locking plate

Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc)

Group Type ACTIVE_COMPARATOR

Proximal femur locking plate

Intervention Type DEVICE

Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)

Trochanteric nail

Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)

Group Type OTHER

Intertrochanteric nail

Intervention Type DEVICE

Intertrochanteric nail (PFNA, TFN, GN)

Interventions

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Proximal femur locking plate

Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)

Intervention Type DEVICE

Intertrochanteric nail

Intertrochanteric nail (PFNA, TFN, GN)

Intervention Type DEVICE

Other Intervention Names

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LCP Proximal Femur Plate (Synthes) LCP Proximal Femur Hook Plate (Synthes) PeriLoc Periarticular Locked Plating System (Smith & Nephew) Proximal Femoral Nail Antirotation (Synthes) Titanium Trochanteric Fixation Nail (Synthes) Gamma Trochanteric Nail (Stryker)

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patients with closed or type 1 open reverse oblique intertrochanteric fractures (AO 31 - A3) or subtrochanteric fractures (transverse fracture line, main fracture line maximum 5 cm distal from the lesser trochanter; proximal extension of fracture allowed)
* Definitive fracture fixation with either a proximal femur locking plate or an intertrochanteric nail within 4 days after accident
* Signed written informed consent (by the subject or legal guardian) and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level

Exclusion Criteria

* Pathologic fracture
* Polytrauma
* Any displacement of a femoral neck fracture
* Additional fracture of one of the lower extremities that significantly affects the functional outcome
* Additional injury of the lower limb that significantly affects the functional outcome
* Fractures of the upper extremity if it affects the mobility of the patient
* Type 2 or 3 open fracture
* Drug or alcohol abuse
* Active malignancy
* ASA class V and VI
* Inability to walk independently prior to injury
* Neurological and psychiatric disorders that would preclude reliable assessment
* Patient is not able to come to the regular FUs
* Patients who have participated in any other device or drug related clinical trial within the previous month
* Pregnancy (tested with a urine pregnancy test) or women planning to conceive within the study period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beate P. Hanson, MD

Role: STUDY_DIRECTOR

AO Clinical Investigation and Documentation, Davos, Switzerland

Locations

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Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Cantonal Hospital Chur

Chur, , Switzerland

Site Status

Cantonal Hospital Lucerne

Lucerne, , Switzerland

Site Status

Countries

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Australia Switzerland

Other Identifiers

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PF LCPs vs Trochanteric Nail

Identifier Type: -

Identifier Source: org_study_id

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