Fractures in the ElderlyFFADNCT06724484
Post-operative Anxiety and Depression Among Older Adults Who Undergo Surgery for Fragility Fractures
An observational study of Fractures in the Elderly, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Patients who present with falls and fractures can experience increased symptoms of depression and anxiety due to the trauma of falling, hospitalisation and surgery. Additionally after surgery, patients may be limited in their mobility, resulting in a loss in their independence which can lead to further feelings of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fractures in the Elderly
- What is being tested?
- Surgical management of fracture
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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: Older adults who are admitted to a tertiary hospital/ major trauma centre with a fragility fracture.
Who may be able to join
- Age 65 years and above
- Received operative or non-operative management of fragility fracture
- Able to provide written consent
Who cannot join
- Patients receiving end of life care
- Patients with known diagnosis of severe dementia and/ or lack capacity to consent
- Non-fragility fracture
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Geriatric Medicine, University of Southampton
Southampton, Hampshire, SO16 6YD
About this study
Patients who present with falls and fractures can experience increased symptoms of depression and anxiety due to the trauma of falling, hospitalisation and surgery. Additionally after surgery, patients may be limited in their mobility, resulting in a loss in their independence which can lead to further feelings of frustration and helplessness. In this study the investigators want to know how common this problem is among older people who are admitted to hospital with broken bones and subsequently receiving surgery.
The investigators will use a questionnaire called the Hospital Anxiety and Depression Scale (HADS) to explore this. We will recruit 60 patients for this study, 30 participants who received operative management and a further 30 participants who did not receive surgery for comparison. Patients who are not able to consent to the study or those who are not able to complete the questionnaire will not be recruited. The investigators will collect routine data from the patients to provide a description of the patients. Patients will complete the HADS questionnaire once during their hospital stay and then in 1 month's time. The investigators will contact patients through telephone for the 1 month follow up.
This study will enable the investigators to determine how common are the symptoms of anxiety and depression among this group of patients. This will help raise awareness of the problem which may prompt further intervention and management plan to address this important issue.
- Conditions
- Fractures in the Elderly
- Being tested
- Surgical management of fracture, No intervention
- Keywords
- Fragility fracture, Anxiety, Depression, Surgery
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical management of fractureProcedure or surgery
Surgical management of fracture
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Fragility fracture receiving surgery | In this group, patients who sustain a fragility fracture and receive surgical intervention will be recruited. Receives: Procedure: Surgical management of fracture | |
| Control | In this group, patients who sustain fragility fracture and receive conservative (non-surgical) management will be recruited. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression scale (HADS) consists of 14 items split into two 7-item subscales for anxiety (HADS-A) and depression (HADS-D), each scored 0-3, with subscale totals ranging from 0 to 21; scores of 0-7 are normal, 8-10 borderline, and 11-21 indicating an abnormal score that will trigger further clinical assessment for anxiety and/or depression.
Measured: This will be measured at baseline and at 1 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 Fractures in the ElderlyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Lim, BM, MRCP (UK), PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724484
- Sponsor's protocol ID
- 94213
- Acronym
- FFAD
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available on the university\'s online repository.
Publications
Frenkel WJ, Jongerius EJ, Mandjes-van Uitert MJ, van Munster BC, de Rooij SE. Validation of the Charlson Comorbidity Index in acutely hospitalized elderly adults: a prospective cohort study. J Am Geriatr Soc. 2014 Feb;62(2):342-6. doi: 10.1111/jgs.12635. Epub 2014 Jan 21.
PubMed 24521366
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Anxiety and Depression Among Older Adults Who Undergo Surgery for Fragility Fractures
- ClinicalTrials.gov ID
- NCT06724484
- Acronym / sponsor ID
- FFAD / 94213
- Conditions
- Fractures in the Elderly
- Keywords
- Fragility fracture, Anxiety, Depression, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Dec 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.
Patients who present with falls and fractures can experience increased symptoms of depression and anxiety due to the trauma of falling, hospitalisation and surgery. Additionally after surgery, patients may be limited in their mobility, resulting in a loss in their independence which can lead to further feelings of frustration and helplessness. In this study the investigators want to know how common this problem is among older people who are admitted to hospital with broken bones and subsequently receiving surgery.
The investigators will use a questionnaire called the Hospital Anxiety and Depression Scale (HADS) to explore this. We will recruit 60 patients for this study, 30 participants who received operative management and a further 30 participants who did not receive surgery for comparison. Patients who are not able to consent to the study or those who are not able to complete the questionnaire will not be recruited. The investigators will collect routine data from the patients to provide a description of the patients. Patients will complete the HADS questionnaire once during their hospital stay and then in 1 month's time. The investigators will contact patients through telephone for the 1 month follow up.
This study will enable the investigators to determine how common are the symptoms of anxiety and depression among this group of patients. This will help raise awareness of the problem which may prompt further intervention and management plan to address this important issue.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fragility fracture receiving surgery | – | Procedure: Surgical management of fractureIn this group, patients who sustain a fragility fracture and receive surgical intervention will be recruited. |
| Control | – | Other: No interventionIn this group, patients who sustain fragility fracture and receive conservative (non-surgical) management will be recruited. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults who are admitted to a tertiary hospital/ major trauma centre with a fragility fracture.
Key inclusion criteria (3 listed)
- Age 65 years and above
- Received operative or non-operative management of fragility fracture
- Able to provide written consent
Key exclusion criteria (3 listed)
- Patients receiving end of life care
- Patients with known diagnosis of severe dementia and/ or lack capacity to consent
- Non-fragility fracture
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 |
|---|---|---|
| Surgical management of fractureSurgical management of fracture | Procedure or surgery | Fragility fracture receiving surgery |
| No interventionNo intervention | Other | Control |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: This will be measured at baseline and at 1 month follow up.
The Hospital Anxiety and Depression scale (HADS) consists of 14 items split into two 7-item subscales for anxiety (HADS-A) and depression (HADS-D), each scored 0-3, with subscale totals ranging from 0 to 21; scores of 0-7 are normal, 8-10 borderline, and 11-21 indicating an abnormal score that will trigger further clinical assessment for anxiety and/or depression.
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 18 May 2026.
- Background: PubMed 24521366Frenkel WJ, Jongerius EJ, Mandjes-van Uitert MJ, van Munster BC, de Rooij SE. Validation of the Charlson Comorbidity Index in acutely hospitalized elderly adults: a prospective cohort study. J Am Geriatr Soc. 2014 Feb;62(2):342-6. doi: 10.1111/jgs.12635. Epub 2014 Jan 21.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available on the university\'s online repository.
Related trials for Fractures in the Elderly
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruitingObservational study
Functional Outcomes in Older Adults With Fragility Fractures of the Pelvis: The FFP-France Study
Fragility Fractures of the Pelvis (FFP), Osteoporotic Fractures
Recruiting
Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization
Thoracolumbar, Fractures in the Elderly
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.
Stephen Lim, BM, MRCP (UK), PhD principal investigator
University of Southampton
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 Fractures in the Elderly, run by University of Southampton at 1 site in United Kingdom.
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 3 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 18 May 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 United Kingdom. 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?
Hospital Anxiety and Depression Scale (time frame: This will be measured at baseline and at 1 month follow up.). 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 NCT06724484, 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 18 May 2026.