NCT05023369 This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
| NCT ID | NCT05023369 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona |
| Condition | Femoral Neck Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-12-10 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2021-12-10 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators are going to evaluate if periarticular corticosteroid injection during endoprothesis implantation can lead to any advantage to the patients, namely if it can reduce post-operative pain, lenght and cost of hospitalisation, use of analgesics drugs.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing unilateral cemented hip endoprosthesis for femoral neck fracture * Patients aged 50-90 years old * Patients with a BMI \>18.5 and \<35 * Patients able to provide informed consent and follow all the study procedures as indicated by the protocol * Informed Consent as documented by signature Exclusion Criteria: * Contraindications to steroids * Revision endoprosthesis * Active steroid or immunosuppressive therapy in the last 30 days before the operation * Pregnant or breast-feeding women * Presence of other clinically significant concomitant disease states (ASA IV) * Uncontrolled diabetes mellitus * Contraindications to NSAIDs * Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus Erythematosus, SLE), gout, rheumatic arthritis * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Participation in another study with investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons.
Contact & Investigator
Christian MD Candrian, Prof.
PRINCIPAL INVESTIGATOR
EOC
Frequently Asked Questions
Who can join the NCT05023369 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Femoral Neck Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05023369 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05023369 currently recruiting?
Yes, NCT05023369 is actively recruiting participants. Contact the research team at Gabriela.Induni-Lang@eoc.ch for enrollment information.
Where is the NCT05023369 trial being conducted?
This trial is being conducted at Lugano, Switzerland.
Who is sponsoring the NCT05023369 clinical trial?
NCT05023369 is sponsored by Ente Ospedaliero Cantonale, Bellinzona. The principal investigator is Christian MD Candrian, Prof. at EOC. The trial plans to enroll 110 participants.