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

Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age

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.

Study Overview

• Status: Completed
• Conditions: the Cement Augmented Screws of TFNA Nails

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consisted of 61 patients. The analyses were therefore based on 45 patients (Table 1). The 38 women and 7 men had a mean age of 82.84 years (65-102, 9.50) and most had sustained AO/OTA 31-A1.2 fractures.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fixation failure rate (cut-out or cut-through)	On X rays	change at 3 and 6 postoperative months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale score	the minimum is 0 and maximum 10, higher scores mean a worse outcome.	at 3 and 6 postoperative months
analysis evaluating quality of reduction	On X rays	once
Augmentation volume		once
length of surgery		at 3 and 6 postoperative months
radiation exposure		once
duration of hospitalisation		once
Intraoperative adverse events		once
EuroQoL 5-Dimensions score	the minimum is 5 and maximum 15, higher scores mean a worse outcome.	change at 3 and 6 postoperative months
Parker Mobility Score	the minimum is 0 and maximum 9, higher scores mean a better outcome.	at 3 and 6 postoperative months
Harris Hip Score	the minimum is 0 and maximum 100, higher scores mean a betteroutcome.	at 3 and 6 postoperative months
the tip-apex distance	On X rays	once
TFNA screw position	On X rays	once
distribution of cement on either side of the cervicocephalic screw	On X rays	once
postoperative complications		at 3 and 6 postoperative months
the need for revision surgery		at 3 and 6 postoperative months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Augmentation; Hip fracture; Cement; TFNA; Cut-out
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: TFNA - 29BRC21.0076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication.
• IPD Sharing Time Frame: Data will be available beginning three years and ending five years following the final study report completion.
• IPD Sharing Access Criteria: Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No