Hip FractureRIC-FRACTURENCT07178041
Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)
A study testing Remote Ischaemic Conditioning in people with Hip Fracture, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Remote Ischaemic Conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged > 18 years)
- Participant has had a hip fracture identified on X-ray or computed tomography (CT) scan.
- Qualifying hip fracture has not occurred more than 7 days prior to enrollment.
- Able to give written informed consent.
- In the opinion of the treating physician would be able to conform to the study protocol and procedures.
Who cannot join
- History or presence of significant peripheral vascular disease in the limb conditioned.
- History or presence of complex neuropathic pains or peripheral neuropathy in the limb conditioned.
- Presence of lymphoedema in the limb conditioned.
- Presence of skin ulceration to the limb conditioned.
- Uncontrolled arrhythmia, hypertension, diabetes or angina.
- Third degree heart block or progressive heart failure.
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- Acute aortic dissection, myocarditis, or pericarditis.
- Acute deep vein thrombosis, pulmonary embolism.
- Suspected or known dissecting aneurysm.
- Stroke or TIA myocardial infarction in the last 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali Ali contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU
About this study
Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture.
Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up.
Read more
Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up.
Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.
Read the detailed description
This is a single centre, single arm feasibility study. The team will aim to recruit 12 participants to complete a programme of RIC for up to 2 weeks following hip fracture or until discharge from hospital or rehabilitation centre.
It is not known whether the main potential protective events resulting from RIC occur due to the short-term effects (likely changes in vascular sensitivity, blood flow etc) or the longer-term effects (modulation of inflammation etc that occur through changes in gene expression). However, the team have chosen a dosing strategy that they feel is practical to deliver given the average length of time people spend in hospital after hip fracture.
- Conditions
- Hip Fracture
- Being tested
- Remote Ischaemic Conditioning
- Keywords
- Hip Fracture, Remote ischaemic conditioning
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic ConditioningProcedure or surgery
Brief episodes of reversible ischaemia are applied to a particular tissue or organ by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. In this study, the treatment will be delivered on the upper arm or unaffected leg.
| Study group | Role | What they receive |
|---|---|---|
| RIC Interventional Arm | Experimental | Participants recruited to this arm will receive a programme of Remote Ischaemic Conditioning for up to 2 weeks following hip fracture, or discharge from hospital or rehabilitation centre. Receives: Procedure: Remote Ischaemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of RIC in patients who have suffered hip fracture
This outcome measure will be assessed by review of their clinical data at baseline and daily intervention visits, review of the side effects during the intervention period and reporting of any AE's throughout the study period. Safety will be defined as;
- No reported SAE's directly related to RIC
- Unexpected adverse events in less than 1/3 participants
Measured: From enrolment to the end of follow up at 3 months
Participant acceptability - Symptom severity scores
This outcome measure will be assessed by review of side effects / adverse events reported to researchers throughout the intervention period. Acceptability will be defined as;
● Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms (based on Likert Scale 1-5; 1 representing no issues; 5 representing severe symptoms)
Measured: From enrolment to end of follow up at 3 months
Participant acceptability - Semi-structured interviews
This outcome measure will be reviewed through the qualitative interviews undertaken in a subset of participants. Acceptability will be defined as;
● Reports from semi-structured interviews
Measured: From enrolment to end of follow up at 3 months
Compliance to the intervention
This outcome measure will be assessed using the patient monitoring diaries. Compliance will be defined as;
● More than 80% of intended RIC cycles completed
Measured: From enrolment to end of treatment at 2 weeks
Study feasibility
This outcome measure will be assessed by review of patient recruitment, completeness of outcome measure assessments recorded and number of follow up assessments completed. Feasibility will be defined as;
- Four patients recruited within the first 2 months of recruitment
- >80% of outcome measure assessments recorded and follow up assessments completed.
Measured: From enrolment to end of follow up at 3 months
Secondary outcomes (7)
Clinical Outcomes - Inpatient Mortality
Explore clinical outcomes including Inpatient mortality (n,%)
Measured: From enrolment to end of follow up at 3 months
Clinical Outcomes - Inpatient Length of Stay
Explore clinical outcomes including Inpatient length of stay (days)
Measured: From enrolment to end of follow up at 3 months
Clinical Outcomes - Rate of inpatient complications
Explore clinical outcomes including Rate of inpatient complications: vascular (venous thromboembolism, acute coronary syndromes, stroke, Transient Ischemic Attack (TIA), systemic embolism, heart failure), infections, renal (acute kidney injury - RIFLE), anaemia (Hb drop ≥ 2g/L) (%)
Measured: From enrolment to end of follow up at 3 months
Clinical Outcomes - Blood pressure
Explore clinical outcomes including Blood pressure (mmHg)
Measured: From enrolment to end of follow up at 3 months
Clinical Outcomes - Function at discharge
Explore clinical outcomes including Function at discharge (Barthel Index)
Measured: From enrolment to end of follow up at 3 months
Clinical Outcomes - Discharge destination
Explore clinical outcomes including Discharge destination
Measured: From enrolment to end of follow up at 3 months
Mechanisms of action
- Inflammatory marker analysis at baseline and 2 weeks or prior to discharge
- Serum catecholamines will also be measured at baseline and 2 weeks or prior to discharge as the stress response may play a critical role in inflammatory response to hip fracture.
Measured: From enrolment to end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start2 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Ali, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178041
- Sponsor's protocol ID
- STH23101
- Acronym
- RIC-FRACTURE
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)
- ClinicalTrials.gov ID
- NCT07178041
- Acronym / sponsor ID
- RIC-FRACTURE / STH23101
- Conditions
- Hip Fracture
- Keywords
- Hip Fracture, Remote ischaemic conditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 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.
Background Hip fracture affects 70,000 people in the United Kingdom (UK) and costs an estimated £1.1 billion per year to the National Health Service (NHS). Key clinical indicators, such as early surgical repair, have been shown to improve patient outcomes, however morbidity and mortality remain extremely high, reflecting the urgent need for novel therapies to enhance outcomes. Common complications include infection, cardiovascular events, falls and venous thromboembolism. Remote Ischaemic Conditioning (RIC) is a treatment whereby a blood pressure cuff is inflated around an arm or leg to above systolic pressures to occlude blood flow to the limb for short periods of time, that do not result in harm, but trigger innate mechanisms that reduce inflammation, improve organ blood flow and improve bone healing. These may be beneficial effects after hip fracture.
Methods This is a single centre, feasibility study; the participants will receive RIC daily for 40 minutes for 10 days during their inpatient stay. Outcome measures relating primarily to safety, tolerability and feasibility will be collected along with compliance with the intervention. Study feasibility will be determined by success criteria based on recruitment, outcome measure assessment compliance with intervention and follow up.
Secondary outcomes including inpatient mortality, inpatient complications, length of inpatient stay, blood pressure, serum inflammatory and stress markers and functional recovery will also be collected at discharge and 3 month follow up.
Results Data collected on safety, tolerability, and feasibility will be presented descriptively and simple analysis of variance will be undertaken on quantitative data such as blood pressure and serum inflammatory and stress markers between baseline and follow up time points. The study will hopefully establish whether this therapy is feasible to deliver after acute hip fracture.
Detailed description
This is a single centre, single arm feasibility study. The team will aim to recruit 12 participants to complete a programme of RIC for up to 2 weeks following hip fracture or until discharge from hospital or rehabilitation centre.
It is not known whether the main potential protective events resulting from RIC occur due to the short-term effects (likely changes in vascular sensitivity, blood flow etc) or the longer-term effects (modulation of inflammation etc that occur through changes in gene expression). However, the team have chosen a dosing strategy that they feel is practical to deliver given the average length of time people spend in hospital after hip fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIC Interventional Arm | Experimental | Procedure: Remote Ischaemic ConditioningParticipants recruited to this arm will receive a programme of Remote Ischaemic Conditioning for up to 2 weeks following hip fracture, or discharge from hospital or rehabilitation centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (aged > 18 years)
- Participant has had a hip fracture identified on X-ray or computed tomography (CT) scan.
- Qualifying hip fracture has not occurred more than 7 days prior to enrollment.
- Able to give written informed consent.
- In the opinion of the treating physician would be able to conform to the study protocol and procedures.
Key exclusion criteria (10 listed)
- History or presence of significant peripheral vascular disease in the limb conditioned.
- History or presence of complex neuropathic pains or peripheral neuropathy in the limb conditioned.
- Presence of lymphoedema in the limb conditioned.
- Presence of skin ulceration to the limb conditioned.
- Uncontrolled arrhythmia, hypertension, diabetes or angina.
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 |
|---|---|---|
| Remote Ischaemic ConditioningBrief episodes of reversible ischaemia are applied to a particular tissue or organ by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. In this study, the treatment will be delivered on the upper arm or unaffected leg. | Procedure or surgery | RIC Interventional Arm |
Primary outcome
Safety of RIC in patients who have suffered hip fracture
Time frame: From enrolment to the end of follow up at 3 months
This outcome measure will be assessed by review of their clinical data at baseline and daily intervention visits, review of the side effects during the intervention period and reporting of any AE's throughout the study period. Safety will be defined as; * No reported SAE's directly related to RIC * Unexpected adverse events in less than 1/3 participants
Participant acceptability - Symptom severity scores
Time frame: From enrolment to end of follow up at 3 months
This outcome measure will be assessed by review of side effects / adverse events reported to researchers throughout the intervention period. Acceptability will be defined as; ● Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms (based on Likert Scale 1-5; 1 representing no issues; 5 representing severe symptoms)
Participant acceptability - Semi-structured interviews
Time frame: From enrolment to end of follow up at 3 months
This outcome measure will be reviewed through the qualitative interviews undertaken in a subset of participants. Acceptability will be defined as; ● Reports from semi-structured interviews
Compliance to the intervention
Time frame: From enrolment to end of treatment at 2 weeks
This outcome measure will be assessed using the patient monitoring diaries. Compliance will be defined as; ● More than 80% of intended RIC cycles completed
Study feasibility
Time frame: From enrolment to end of follow up at 3 months
This outcome measure will be assessed by review of patient recruitment, completeness of outcome measure assessments recorded and number of follow up assessments completed. Feasibility will be defined as; * Four patients recruited within the first 2 months of recruitment * >80% of outcome measure assessments recorded and follow up assessments completed.
7 secondary outcomes
Clinical Outcomes - Inpatient Mortality
Time frame: From enrolment to end of follow up at 3 months
Clinical Outcomes - Inpatient Length of Stay
Time frame: From enrolment to end of follow up at 3 months
Clinical Outcomes - Rate of inpatient complications
Time frame: From enrolment to end of follow up at 3 months
Clinical Outcomes - Blood pressure
Time frame: From enrolment to end of follow up at 3 months
Clinical Outcomes - Function at discharge
Time frame: From enrolment to end of follow up at 3 months
Clinical Outcomes - Discharge destination
Time frame: From enrolment to end of follow up at 3 months
Mechanisms of action
Time frame: From enrolment to end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Ali Ali contact
Ali Ali principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning in people with Hip Fracture, run by Sheffield Teaching Hospitals NHS Foundation Trust 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Wilkinson (0114 271 1658, sarah.wilkinson71@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of RIC in patients who have suffered hip fracture (time frame: From enrolment to the end of follow up at 3 months). The study lists 5 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 17 Sep 2025.