Femur FractureNCT05225753
Post-operative Anemia in Lateral Fractures of the Femur.
An observational study of Femur Fracture, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- hemoglobin serum value
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2020to 1 Sep 2021
- 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: Fortyfive (45) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between November 2020 and September 2021 with lateral fragility fracture were prospectively recruited.
Who may be able to join
- femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.);
- age more than 65 years;
Who cannot join
- patients with neurological diseases;
- finding of anemia before surgery;
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, 70124
About this study
Official title: Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails
It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes).
One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.
- Conditions
- Femur Fracture
- Being tested
- hemoglobin serum value
- Keywords
- fragility lateral femoral fractures, intramedullary nail, Post-operative anemia, surgical time, Blood transfusions number
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoglobin serum valueDiagnostic test
post-operative anemia evaluated with hemoglobin serum value
| Study group | Role | What they receive |
|---|---|---|
| patients treated with Affixus Zimmer-Biomet | Not described Receives: Diagnostic Test: hemoglobin serum value | |
| patients treated with EBA2 Citieffe | Not described Receives: Diagnostic Test: hemoglobin serum value | |
| patients treated with Proximal Femoral Nail Antirotation Synthes | Not described Receives: Diagnostic Test: hemoglobin serum value |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin serum value
Post-operative anemia was quantified using the hemoglobin serum value ranging between more than 10 g/dl (no post-operative anemia) and less than 10 g/dl (post-operative anemia).
Measured: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Nov 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedali Riuniti di Foggia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225753
- Sponsor's protocol ID
- Post-op Anemia
- Status last verified
- Dec 2021
- First submitted
- 19 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails
- ClinicalTrials.gov ID
- NCT05225753
- Acronym / sponsor ID
- Post-op Anemia
- Conditions
- Femur Fracture
- Keywords
- fragility lateral femoral fractures, intramedullary nail, Post-operative anemia, surgical time, Blood transfusions number
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Ospedali Riuniti di Foggia
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 7 Feb 2022 (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.
It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes).
One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients treated with Affixus Zimmer-Biomet | – | Diagnostic Test: hemoglobin serum value |
| patients treated with EBA2 Citieffe | – | Diagnostic Test: hemoglobin serum value |
| patients treated with Proximal Femoral Nail Antirotation Synthes | – | Diagnostic Test: hemoglobin serum value |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Fortyfive (45) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between November 2020 and September 2021 with lateral fragility fracture were prospectively recruited.
Key inclusion criteria (2 listed)
- femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.);
- age more than 65 years;
Key exclusion criteria (2 listed)
- patients with neurological diseases;
- finding of anemia before surgery;
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 |
|---|---|---|
| hemoglobin serum valuepost-operative anemia evaluated with hemoglobin serum value | Diagnostic test | patients treated with Affixus Zimmer-Biomet, patients treated with EBA2 Citieffe, patients treated with Proximal Femoral Nail Antirotation Synthes |
Primary outcome
Change in hemoglobin serum value
Time frame: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)
Post-operative anemia was quantified using the hemoglobin serum value ranging between more than 10 g/dl (no post-operative anemia) and less than 10 g/dl (post-operative anemia).
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 7 Feb 2022.
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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?
An observational study of Femur Fracture, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 2 inclusion and 2 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 7 Feb 2022. 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 Italy. 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?
Change in hemoglobin serum value (time frame: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)). 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 7 Feb 2022.