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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04993053
Acronym
TFNA
Enrollment
61
Registered
2021-08-06
Start date
2019-06-20
Completion date
2020-09-15
Last updated
2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Cement Augmented Screws of TFNA Nails

Keywords

TFNA, Hip fracture, Augmentation, Cement, Cut-out

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Fixation failure rate (cut-out or cut-through)change at 3 and 6 postoperative monthsOn X rays

Secondary

MeasureTime frameDescription
Parker Mobility Scoreat 3 and 6 postoperative monthsthe minimum is 0 and maximum 9, higher scores mean a better outcome.
Harris Hip Scoreat 3 and 6 postoperative monthsthe minimum is 0 and maximum 100, higher scores mean a betteroutcome.
the tip-apex distanceonceOn X rays
TFNA screw positiononceOn X rays
distribution of cement on either side of the cervicocephalic screwonceOn X rays
postoperative complicationsat 3 and 6 postoperative months
the need for revision surgeryat 3 and 6 postoperative months
EuroQoL 5-Dimensions scorechange at 3 and 6 postoperative monthsthe minimum is 5 and maximum 15, higher scores mean a worse outcome.
analysis evaluating quality of reductiononceOn X rays
Augmentation volumeonce
length of surgeryat 3 and 6 postoperative months
radiation exposureonce
duration of hospitalisationonce
Intraoperative adverse eventsonce
Visual Analogue Scale scoreat 3 and 6 postoperative monthsthe minimum is 0 and maximum 10, higher scores mean a worse outcome.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026