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

Completed

• Conditions: the Cement Augmented Screws of TFNA Nails

• Registration Number: NCT04993053
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-06-20
• Primary Completion: 2020-06-03
• Study Completion: 2020-09-15
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fixation failure rate (cut-out or cut-through)	change at 3 and 6 postoperative months	On X rays

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France