Skip to main content
Clinical Trials/NCT04993053
NCT04993053
Completed
N/A

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

University Hospital, Brest1 site in 1 country61 target enrollmentJune 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
the Cement Augmented Screws of TFNA Nails
Sponsor
University Hospital, Brest
Enrollment
61
Locations
1
Primary Endpoint
Fixation failure rate (cut-out or cut-through)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2019
End Date
September 15, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Fixation failure rate (cut-out or cut-through)

Time Frame: change at 3 and 6 postoperative months

On X rays

Secondary Outcomes

  • duration of hospitalisation(once)
  • EuroQoL 5-Dimensions score(change at 3 and 6 postoperative months)
  • length of surgery(at 3 and 6 postoperative months)
  • Harris Hip Score(at 3 and 6 postoperative months)
  • TFNA screw position(once)
  • the need for revision surgery(at 3 and 6 postoperative months)
  • analysis evaluating quality of reduction(once)
  • Augmentation volume(once)
  • radiation exposure(once)
  • Intraoperative adverse events(once)
  • Visual Analogue Scale score(at 3 and 6 postoperative months)
  • Parker Mobility Score(at 3 and 6 postoperative months)
  • distribution of cement on either side of the cervicocephalic screw(once)
  • postoperative complications(at 3 and 6 postoperative months)
  • the tip-apex distance(once)

Study Sites (1)

Loading locations...

Similar Trials