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NCT04993053: TFNA
Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures
trial in the Cement Augmented Screws of TFNA Nails in 61 participants. Completed in 15 September 2020.
3 June 2020
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 61 |
| Start date | 20 June 2019 |
| Primary completion | 3 June 2020 |
| Estimated completion | 15 September 2020 |
| Sites | 1 location across France |
Conditions studied
- the Cement Augmented Screws of TFNA Nails — all drugs for the Cement Augmented Screws of TFNA Nails →
Sponsor
University Hospital, Brest
Who can join
65 and older, any sex, with the Cement Augmented Screws of TFNA Nails. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04993053
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04993053 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 6 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04993053.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing