Geriatric Hip FractureNCT06598566
A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.
An observational study of Geriatric Hip Fracture, run by Tata Main Hospital at 1 site in India.
Trial summary
This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric Hip Fracture
- What is being tested?
- Nottingham Hip Fracture Score (NHFS) score and Acute Physiology and Chronic Health Evaluation (APACHE)-II score
- How many people
- 182 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jun 2022to 19 Jun 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for elective surgery for fractures around the hip joint at at Tata main hospital, Jamshedpur, India
Inclusion Criteria: Age more than or equal to 60 years, Underwent Hip fracture surgeries, of Either Sex
-
Exclusion Criteria: Age less than 60 years of age, Hip fractures not undergoing any invasive surgery, Implant removals planned for healed hip fractures, Re-explorations during the same admission in which primary surgery was conducted
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Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery.
Read the detailed description
The study aim to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years undergoing hip fracture surgery. This study was conducted at the Tata Main Hospital in Jamshedpur, India. The study was designed as a prospective observational study, with data collected from June 2022 to June 2023. The study's primary objective was to predict mortality in patients undergoing hip fracture surgery. The study also investigated secondary outcomes such as the need for postoperative ventilator and ionotropic support, the occurrence of acute kidney injury, cardiac morbidity, and the presence of pulmonary embolism and deep vein thrombosis, as well as length of stay.
- Conditions
- Geriatric Hip Fracture
- Being tested
- Nottingham Hip Fracture Score (NHFS) score, Acute Physiology and Chronic Health Evaluation (APACHE)-II score
- Keywords
- Geriatrics, Hip Fractures, APACHE II, Mortality, Morbidity
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nottingham Hip Fracture Score (NHFS) scoreOther
Nottingham Hip Fracture Score (NHFS) score in patients above 60 years undergoing hip fracture surgery.
Acute Physiology and Chronic Health Evaluation (APACHE)-II scoreOther
Acute Physiology and Chronic Health Evaluation (APACHE)-II score in patients above 60 years undergoing hip fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| Geriatric patients above 60 years undergoing hip fracture surgery | Efficacy of NHFS and APACHE-II in predicting 30-day mortality in geriatric patients above 60 years undergoing hip fracture surgery. Receives: Other: Nottingham Hip Fracture Score (NHFS) score; Other: Acute Physiology and Chronic Health Evaluation (APACHE)-II score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality at least 30 days after surgery or death (during hospital stay or within 30 days after surgery.
Measured: 30 days
Secondary outcomes (1)
Length of Stay (LOS)
Length of Stay (LOS) in the hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Jun 2022
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric Hip 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Main Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Deb Sanjay Nag, Tata Main Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598566
- Sponsor's protocol ID
- 2122100200
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Being a GDPR compliant organization, data privacy officer\'s consent may be needed. It has not been taken yet. However, masked data maybe considered if approved by the organization.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT06598566
- Acronym / sponsor ID
- 2122100200
- Conditions
- Geriatric Hip Fracture
- Keywords
- Geriatrics, Hip Fractures, APACHE II, Mortality, Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Tata Main HospitalUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 19 Sep 2024 (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.
This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery.
Detailed description
The study aim to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years undergoing hip fracture surgery. This study was conducted at the Tata Main Hospital in Jamshedpur, India. The study was designed as a prospective observational study, with data collected from June 2022 to June 2023. The study's primary objective was to predict mortality in patients undergoing hip fracture surgery. The study also investigated secondary outcomes such as the need for postoperative ventilator and ionotropic support, the occurrence of acute kidney injury, cardiac morbidity, and the presence of pulmonary embolism and deep vein thrombosis, as well as length of stay.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric patients above 60 years undergoing hip fracture surgery | – | Other: Nottingham Hip Fracture Score (NHFS) score, Other: Acute Physiology and Chronic Health Evaluation (APACHE)-II scoreEfficacy of NHFS and APACHE-II in predicting 30-day mortality in geriatric patients above 60 years undergoing hip fracture surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for elective surgery for fractures around the hip joint at at Tata main hospital, Jamshedpur, India
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 |
|---|---|---|
| Nottingham Hip Fracture Score (NHFS) scoreNottingham Hip Fracture Score (NHFS) score in patients above 60 years undergoing hip fracture surgery. | Other | Geriatric patients above 60 years undergoing hip fracture surgery |
| Acute Physiology and Chronic Health Evaluation (APACHE)-II scoreAcute Physiology and Chronic Health Evaluation (APACHE)-II score in patients above 60 years undergoing hip fracture surgery | Other | Geriatric patients above 60 years undergoing hip fracture surgery |
Primary outcome
Mortality
Time frame: 30 days
Mortality at least 30 days after surgery or death (during hospital stay or within 30 days after surgery.
1 secondary outcome
Length of Stay (LOS)
Time frame: 30 days
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided. Being a GDPR compliant organization, data privacy officer\'s consent may be needed. It has not been taken yet. However, masked data maybe considered if approved by the organization.
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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 Geriatric Hip Fracture, run by Tata Main Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Sep 2024. 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 India. 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?
Mortality (time frame: 30 days). 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 19 Sep 2024.