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Completed

NCT Number: NCT04993053

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: change at 3 and 6 postoperative months

    On X rays

Secondary outcomes

  1. Visual Analogue Scale score

    Time frame: at 3 and 6 postoperative months

    the minimum is 0 and maximum 10, higher scores mean a worse outcome.

  2. analysis evaluating quality of reduction

    Time frame: once

    On X rays

  3. Augmentation volume

    Time frame: once

  4. length of surgery

    Time frame: at 3 and 6 postoperative months

  5. radiation exposure

    Time frame: once

  6. duration of hospitalisation

    Time frame: once

  7. Intraoperative adverse events

    Time frame: once

  8. EuroQoL 5-Dimensions score

    Time frame: change at 3 and 6 postoperative months

    the minimum is 5 and maximum 15, higher scores mean a worse outcome.

  9. Parker Mobility Score

    Time frame: at 3 and 6 postoperative months

    the minimum is 0 and maximum 9, higher scores mean a better outcome.

  10. Harris Hip Score

    Time frame: at 3 and 6 postoperative months

    the minimum is 0 and maximum 100, higher scores mean a betteroutcome.

  11. the tip-apex distance

    Time frame: once

    On X rays

  12. TFNA screw position

    Time frame: once

    On X rays

  13. distribution of cement on either side of the cervicocephalic screw

    Time frame: once

    On X rays

  14. postoperative complications

    Time frame: at 3 and 6 postoperative months

  15. the need for revision surgery

    Time frame: at 3 and 6 postoperative months

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: TFNA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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