This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time

NCT05023369 | Recruiting Phase 4

• 1 other identifier: ORL - ORT - 028
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)

  3 days after surgery

Secondary Outcomes (11)

• Hip pain and function on a numeric rating scale (NRS)

  Up to 24 months

• Hip pain, function and quality of life on Harris Hip Score

  Up to 24 months

• Hip pain, function and quality of life on EQ-5D-5L Score

  Up to 24 months

• PainDETECT

  Up to 24 months

• Nausea

  3 days after surgery

Study Arms (2)

Dexamethasone group

EXPERIMENTAL

Patient in this group will receive administration of 9 mg dexamethasone injected in the peri-articular tissues after the bone cut for hip endoprosthesis

Drug: Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)

Routine care

NO INTERVENTION

In this group only routinely performed anaesthesia protocol will be provided

Interventions

Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml) DRUG

Dexamethasone will be administered as an injectable solution (4mg/ml). Every ml of this solution contains 4 mg of dexamethasone sodium phosphate, corresponding to 3 mg of dexamethasone. Thus 3 ml of solution will be injected peri-articularly (arm-A)

Also known as: Mephameson

Dexamethasone group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Christian Candrian

Lugano, 6900, Switzerland

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian MD Candrian, Prof.

  EOC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian MD Candrian, Prof.

CONTACT

0041918117029; Gabriela.Induni-Lang@eoc.ch

Gabriela Induni-Lang

CONTACT

0041918117029; Gabriela.Induni-Lang@eoc.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 26, 2021
• Study Start: December 10, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)