Femoral FracturesALGOFRACTNCT03185663
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
A study testing traction-stuck and a pillow between the legs in people with Femoral Fractures, run by University Hospital, Limoges at 1 site in France.
Trial summary
The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- traction-stuck and a pillow between the legs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2017to 25 May 2021
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient aged 70 and over,
- Extracapsular fracture isolated from the proximal end of the femur,
- Informed consent of the patient for participation in the study,
- Patient affiliated to a social security scheme.
Who cannot join
- Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively
- Insane or confounding Pathology,
- Predictable time before operation> to 72 hours (eg anticoagulated patient orally before the fracture [antiplatelet agents are allowed], other associated diseases: urinary tract infection, pneumonia ...)
- Patient under guardianship, curatorship, or under judicial protection.
Trial locations and contacts
1 site in 1 country.
About this study
The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.
759/5000
- Conditions
- Femoral Fractures
- Being tested
- traction-stuck, a pillow between the legs
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traction-stuckOther
continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight
a pillow between the legsOther
setting up a pillow between the legs before the care
| Study group | Role | What they receive |
|---|---|---|
| a pillow between the legs | Placebo comparator | Not described Receives: Other: a pillow between the legs |
| traction-stuck | Experimental | Not described Receives: Other: traction-stuck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score from pain immediately after washing, the day of surgery preoperatively
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start31 Aug 2017
- Primary completion30 Oct 2020
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a pillow between the legs versus traction-stuck
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185663
- Sponsor's protocol ID
- I15010 / ALGOFRACT
- Acronym
- ALGOFRACT
- Status last verified
- Nov 2020
- First submitted
- 12 Jun 2017
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://doi.org/10.2139/ssrn.4132025
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur
- ClinicalTrials.gov ID
- NCT03185663
- Acronym / sponsor ID
- ALGOFRACT / I15010 / ALGOFRACT
- Conditions
- Femoral Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 14 Jun 2017 (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.
The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.
759/5000
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a pillow between the legs versus traction-stuck
| Arm | Type | Receives |
|---|---|---|
| a pillow between the legs | Placebo comparator | Other: a pillow between the legs |
| traction-stuck | Experimental | Other: traction-stuck |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient aged 70 and over,
- Extracapsular fracture isolated from the proximal end of the femur,
- Informed consent of the patient for participation in the study,
- Patient affiliated to a social security scheme.
Key exclusion criteria (4 listed)
- Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively
- Insane or confounding Pathology,
- Predictable time before operation> to 72 hours (eg anticoagulated patient orally before the fracture [antiplatelet agents are allowed], other associated diseases: urinary tract infection, pneumonia ...)
- Patient under guardianship, curatorship, or under judicial protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traction-stuckcontinuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight | Other | traction-stuck |
| a pillow between the legssetting up a pillow between the legs before the care | Other | a pillow between the legs |
Primary outcome
Score from pain immediately after washing, the day of surgery preoperatively
Time frame: 5 minutes
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 27 Mar 2026.
- Results publicationhttps://doi.org/10.2139/ssrn.4132025
- Individual participant dataSharing planned: No
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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?
A study testing traction-stuck and a pillow between the legs in people with Femoral Fractures, run by University Hospital, Limoges 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 4 inclusion and 4 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 27 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
Score from pain immediately after washing, the day of surgery preoperatively (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185663, which also lists 1 linked publication.
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 27 Mar 2026.