Remote Ischaemic Conditioning for Post-surgical Complications in Hip Fracture (RIC-FRACTURE)

NCT07178041 | Recruiting

• 1 other identifier: STH23101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Hip Fracture

Keywords

Hip Fracture; Remote ischaemic conditioning

Outcome Measures

Primary Outcomes (5)

• 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

  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)

  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

  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

  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.

  From enrolment to end of follow up at 3 months

Secondary Outcomes (7)

• Clinical Outcomes - Inpatient Mortality

  From enrolment to end of follow up at 3 months

• Clinical Outcomes - Inpatient Length of Stay

  From enrolment to end of follow up at 3 months

• Clinical Outcomes - Rate of inpatient complications

  From enrolment to end of follow up at 3 months

• Clinical Outcomes - Blood pressure

  From enrolment to end of follow up at 3 months

• Clinical Outcomes - Function at discharge

  From enrolment to end of follow up at 3 months

Study Arms (1)

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.

Procedure: Remote Ischaemic Conditioning

Interventions

Remote Ischaemic Conditioning PROCEDURE

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.

RIC Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Ali Ali

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Wilkinson

CONTACT

0114 271 1658; sarah.wilkinson71@nhs.net

Ali Ali

CONTACT

Ali.ali@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: September 17, 2025
• Study Start: August 2, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

GB (1)