Clinical trial NCT04993053: Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures
Official title: Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Cement Augmented Screws of TFNA Nails
Keywords: TFNA
Hip fracture
Augmentation
Cement
Cut-out
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Fixation failure rate (cut-out or cut-through)
timeFrame: change at 3 and 6 postoperative months
Secondary outcomes:
measure: Visual Analogue Scale score
timeFrame: at 3 and 6 postoperative months
measure: analysis evaluating quality of reduction
timeFrame: once
measure: Augmentation volume
timeFrame: once
measure: length of surgery
timeFrame: at 3 and 6 postoperative months
measure: radiation exposure
timeFrame: once
measure: duration of hospitalisation
timeFrame: once
measure: Intraoperative adverse events
timeFrame: once
measure: EuroQoL 5-Dimensions score
timeFrame: change at 3 and 6 postoperative months
measure: Parker Mobility Score
timeFrame: at 3 and 6 postoperative months
measure: Harris Hip Score
timeFrame: at 3 and 6 postoperative months
measure: the tip-apex distance
timeFrame: once
measure: TFNA screw position
timeFrame: once
measure: distribution of cement on either side of the cervicocephalic screw
timeFrame: once
measure: postoperative complications
timeFrame: at 3 and 6 postoperative months
measure: the need for revision surgery
timeFrame: at 3 and 6 postoperative months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References: