Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures

NCT ID: NCT04993053

Last Updated: 2021-08-06

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

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-20

Study Completion Date

2020-09-15

Brief Summary

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Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were \> 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.

Detailed Description

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Conditions

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the Cement Augmented Screws of TFNA Nails

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* \> 65 years of age
* a trochanteric fracture that occurred through a low-energy mechanism
* an augmented TFNA nail

Exclusion Criteria

* pathological fracture
* open fracture
* hips with pre-existing deformities other than osteoarthritis
* a history of hip surgery
* an insufficient quantity of injected cement (\< 3 mL).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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TFNA - 29BRC21.0076

Identifier Type: -

Identifier Source: org_study_id

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