Intertrochanteric FracturesNCT07159945
Controlling Nutritional Status as a Superior Predictor of Fixation Failure in Intertrochanteric Fractures: Development and Validation of a Multicentre Nomogram
An observational study of Intertrochanteric Fractures and Internal Fixation Failure, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intertrochanteric Fractures, Internal Fixation Failure, CONUT Score
- How many people
- 1,296 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to inclusion criteria, 1,296 patients undergoing internal fixation for intertrochanteric fractures at the aforementioned medical institutions between 2020 and 2024 were selected. All patients completed at least one year of follow-up. Follow-up comprised comprehensive orthopaedic examinations and serological tests, supplemented by repeat imaging where necessary to assess local fracture/internal fixation status.
Who may be able to join
- 1. Diagnosis of ITF on the basis of medical history, symptoms, imaging data, etc.; 2. Treatment by internal fixation surgery; 3. Normal cognitive function; and 4. Informed consent obtained from the patient or family.
Who cannot join
- 1. Significant missing data: In accordance with the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement, only cases with complete key variables (missing rate <5%) were included; 2. Severe preoperative systemic comorbidities (e.g., decompensated liver/renal failure, active pneumonia, malignancy, and cachexia) and/or a history of mental illness; and 3. Missing postoperative follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.
Read the detailed description
A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. Detailed documentation of patient information, including age, gender, affected side, bone mineral density (BMD), age-adjusted Charlson Comorbidity Index (aCCI), fracture type, internal fixation method, haematological parameters, implant-related complications (INSTs), and reasons for failure. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.
- Conditions
- Intertrochanteric Fractures, Internal Fixation Failure, CONUT Score, Nomogram Model, Nutritional Status
- Keywords
- Intertrochanteric Fractures, Internal fixation failure, CONUT score, Nomogram model, Nutritional Status
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FIF-ITF group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The CONUT score
Measured: Before surgery
The PNI score
Measured: Before surgery
The NPS score
Measured: Before surgery
Secondary outcomes (6)
serum albumin
Measured: Before surgery
total cholesterol
Measured: Before surgery
lymphocyte count
Measured: Before surgery
fracture type
Measured: Before surgery
age
Measured: Before surgery
osteoporosis
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric FracturesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Fang, First Affiliated Hospital of Fujian Medical University
- Investigators
- Liu Zhang, MD, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159945
- Sponsor's protocol ID
- MTCA,ECFAH Of FMU [2015]084 -2
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Nutritional Status as a Superior Predictor of Fixation Failure in Intertrochanteric Fractures: Development and Validation of a Multicentre Nomogram
- ClinicalTrials.gov ID
- NCT07159945
- Acronym / sponsor ID
- MTCA,ECFAH Of FMU [2015]084 -2
- Conditions
- Intertrochanteric Fractures, Internal Fixation Failure, CONUT Score, Nomogram Model, Nutritional Status
- Keywords
- Intertrochanteric Fractures, Internal fixation failure, CONUT score, Nomogram model, Nutritional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Sep 2025 (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.
A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.
Detailed description
A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. Detailed documentation of patient information, including age, gender, affected side, bone mineral density (BMD), age-adjusted Charlson Comorbidity Index (aCCI), fracture type, internal fixation method, haematological parameters, implant-related complications (INSTs), and reasons for failure. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIF-ITF group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to inclusion criteria, 1,296 patients undergoing internal fixation for intertrochanteric fractures at the aforementioned medical institutions between 2020 and 2024 were selected. All patients completed at least one year of follow-up. Follow-up comprised comprehensive orthopaedic examinations and serological tests, supplemented by repeat imaging where necessary to assess local fracture/internal fixation status.
Key inclusion criteria (1 listed)
- 1. Diagnosis of ITF on the basis of medical history, symptoms, imaging data, etc.; 2. Treatment by internal fixation surgery; 3. Normal cognitive function; and 4. Informed consent obtained from the patient or family.
Key exclusion criteria (1 listed)
- 1. Significant missing data: In accordance with the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement, only cases with complete key variables (missing rate <5%) were included; 2. Severe preoperative systemic comorbidities (e.g., decompensated liver/renal failure, active pneumonia, malignancy, and cachexia) and/or a history of mental illness; and 3. Missing postoperative follow-up.
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
The CONUT score
Time frame: Before surgery
The PNI score
Time frame: Before surgery
The NPS score
Time frame: Before surgery
6 secondary outcomes
serum albumin
Time frame: Before surgery
total cholesterol
Time frame: Before surgery
lymphocyte count
Time frame: Before surgery
fracture type
Time frame: Before surgery
age
Time frame: Before surgery
osteoporosis
Time frame: Before surgery
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 8 Sep 2025.
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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.
Liu Zhang, MD study director
First Affiliated Hospital of Fujian Medical University
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 Intertrochanteric Fractures and Internal Fixation Failure, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
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 1 inclusion and 1 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 8 Sep 2025. 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 China. 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?
The CONUT score (time frame: Before surgery). The study lists 3 primary outcomes in all. 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 8 Sep 2025.