the Cement Augmented Screws of TFNA NailsTFNANCT04993053
Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures
An observational study of the Cement Augmented Screws of TFNA Nails, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- the Cement Augmented Screws of TFNA Nails
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2019to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- > 65 years of age
- a trochanteric fracture that occurred through a low-energy mechanism
- an augmented TFNA nail
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age
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.
- Keywords
- TFNA, Hip fracture, Augmentation, Cement, Cut-out
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation failure rate (cut-out or cut-through)
On X rays
Measured: change at 3 and 6 postoperative months
Secondary outcomes (15)
Visual Analogue Scale score
the minimum is 0 and maximum 10, higher scores mean a worse outcome.
Measured: at 3 and 6 postoperative months
analysis evaluating quality of reduction
On X rays
Measured: once
Augmentation volume
Measured: once
length of surgery
Measured: at 3 and 6 postoperative months
radiation exposure
Measured: once
duration of hospitalisation
Measured: once
Intraoperative adverse events
Measured: once
EuroQoL 5-Dimensions score
the minimum is 5 and maximum 15, higher scores mean a worse outcome.
Measured: change at 3 and 6 postoperative months
Parker Mobility Score
the minimum is 0 and maximum 9, higher scores mean a better outcome.
Measured: at 3 and 6 postoperative months
Harris Hip Score
the minimum is 0 and maximum 100, higher scores mean a betteroutcome.
Measured: at 3 and 6 postoperative months
the tip-apex distance
On X rays
Measured: once
TFNA screw position
On X rays
Measured: once
distribution of cement on either side of the cervicocephalic screw
On X rays
Measured: once
postoperative complications
Measured: at 3 and 6 postoperative months
the need for revision surgery
Measured: at 3 and 6 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start20 Jun 2019
- Primary completion3 Jun 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Cement Augmented Screws of TFNA NailsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993053
- Sponsor's protocol ID
- TFNA - 29BRC21.0076
- Acronym
- TFNA
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT04993053
- Acronym / sponsor ID
- TFNA / TFNA - 29BRC21.0076
- Keywords
- TFNA, Hip fracture, Augmentation, Cement, Cut-out
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- > 65 years of age
- a trochanteric fracture that occurred through a low-energy mechanism
- an augmented TFNA nail
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fixation failure rate (cut-out or cut-through)
Time frame: change at 3 and 6 postoperative months
On X rays
15 secondary outcomes
Visual Analogue Scale score
Time frame: at 3 and 6 postoperative months
analysis evaluating quality of reduction
Time frame: once
Augmentation volume
Time frame: once
length of surgery
Time frame: at 3 and 6 postoperative months
radiation exposure
Time frame: once
duration of hospitalisation
Time frame: once
Intraoperative adverse events
Time frame: once
EuroQoL 5-Dimensions score
Time frame: change at 3 and 6 postoperative months
Parker Mobility Score
Time frame: at 3 and 6 postoperative months
Harris Hip Score
Time frame: at 3 and 6 postoperative months
the tip-apex distance
Time frame: once
TFNA screw position
Time frame: once
distribution of cement on either side of the cervicocephalic screw
Time frame: once
postoperative complications
Time frame: at 3 and 6 postoperative months
the need for revision surgery
Time frame: at 3 and 6 postoperative months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Cement Augmented Screws of TFNA Nails, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fixation failure rate (cut-out or cut-through) (time frame: change at 3 and 6 postoperative months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.