Femoral Neck FracturesPhase 4NCT05023369
This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
A Phase 4 study testing Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml) in people with Femoral Neck Fractures, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2021to 1 Nov 2027
- Phase
- Phase 4
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Christian Candrian
Lugano, 6900
Christian Candrian, Prof.Dr.med, +41 (0) 91 811 61 23, christian.candrian@eoc.ch
Gianluigi Capone, Dr., gianluigi.capone@eoc.ch
About this study
Official title: Periarticular Administration of Dexamethasone to Improve Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Hip Arthroplasty - A Randomized Trial
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.
Read the detailed description
Hip endoprothesis is a common orthopaedic prosthetic procedure, with continuously growing numbers in the last years, and the demand for this procedure is predicted to increase 4-fold by 2030. Recently, major interest has been given to improve postoperative pain management, to decrease the discomfort of the patients and with an outlook for reducing the length of hospital stay and decrease health-care costs. However, postoperative pain management is still problematic after this operation.
Post-operative pain control with the optimization of the analgesia protocol is a key aspect to be addressed to reduce the need for opioid analgesics, to quicken recovery and mobilisation, and to decrease the hospitalization length. To this regard, steroid supplementation is considered effective in decreasing post-operative pain. A recent meta-analysis from our research group on patients with total knee prosthesis proved the efficacy in decreasing post-operative pain. Moreover, a positive effect has been documented in terms of lower incidence of nausea and vomit, less post-operative range of motion limitation, and decreased systemic inflammatory response. All these benefits produced a shortened length of hospital stay without an increased risk of complications such as local infections.
Despite this overall positive effect of steroid supplementation, and their use by other specialties - e.g. anaesthesiology - and while there is now good evidence about the benefits of periarticular hip analgesic injection, e.g. FANS, opioid etc., there is still lacking evidence on the efficacy of periarticular corticosteroids in patients undergoing hip prosthetic replacement. In fact, there is a lack of information in the literature on their effectiveness in terms of pain management and function recovery. Furthermore, the influence of perioperative steroid application on the long-term follow-up results is poorly explored. This is a key issue, since the intensity of acute post-operative pain has been widely related to the risk of developing chronic post-operative pain, and thus the advantages of steroid supplementation, could go beyond the short-term pain relief and be even longer lasting.
This randomized controlled trial will thus investigate the benefit of implementing the peri-operative analgesia protocol not only to improve the acute post-operative recovery and shorten the hospital stay, but also to optimize the overall results after hip endoprosthesis.
- Conditions
- Femoral Neck Fractures
- Being tested
- Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)Drug
Also called Mephameson
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)
Measured: 3 days after surgery
Secondary outcomes (11)
Hip pain and function on a numeric rating scale (NRS)
Hip pain and general function documented on a 0-10 NRS preoperatively and during the first 3 months, and reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
Measured: Up to 24 months
Hip pain, function and quality of life on Harris Hip Score
hip pain, function and quality of life evaluated by the validated clinical Harris Hip Score preoperatively and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.
The Harris Hip Score is a measure of dysfunction; the maximum score possible is 100 and the higher the score, the better the outcome for the individual.
Measured: Up to 24 months
Hip pain, function and quality of life on EQ-5D-5L Score
hip pain, function and quality of life evaluated by the validated patient reported outcome measures EQ-5D-5L Scores preoperatively and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively
Measured: Up to 24 months
PainDETECT
PainDETECT questionnaire for identifying neuropathic pain component and patient satisfaction on a two-level scale at 6, 12, 24 months
Measured: Up to 24 months
Nausea
Post-operative nausea documented during the 3 first post-operative days (both incidence and intensity on a 0-10 NRS)
Measured: 3 days after surgery
Opioids and analgesic
Post-operative opioids and analgesic drugs consumption documented with Medication Quantification Scale score (MQS) daily during the first 6 weeks and then at 3, 6, 12, 24 months postoperatively
Measured: Up to 24 months
PCR & ESR
Post-operative inflammatory response in terms of hematic C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR) documented every day in the first 3 post-operative days
Measured: 3 days after surgery
Mobilization
Time from surgery to first mobilization
Measured: Up to week 2
Length of hospital stay
The length of hospital stay
Measured: Up to week 2
Patient Satisfaction
the satisfaction of the patient with the surgical procedure
Measured: reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
Hip ROM
range of movement of the operated hip
Measured: evaluation of range of motion preoperatively, at discharge and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start10 Dec 2021
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian MD Candrian, Prof., Principal investigator, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023369
- Sponsor's protocol ID
- ORL - ORT - 028
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periarticular Administration of Dexamethasone to Improve Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Hip Arthroplasty - A Randomized Trial
- ClinicalTrials.gov ID
- NCT05023369
- Acronym / sponsor ID
- ORL - ORT - 028
- Conditions
- Femoral Neck Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 Aug 2021 (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.
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.
Detailed description
Hip endoprothesis is a common orthopaedic prosthetic procedure, with continuously growing numbers in the last years, and the demand for this procedure is predicted to increase 4-fold by 2030. Recently, major interest has been given to improve postoperative pain management, to decrease the discomfort of the patients and with an outlook for reducing the length of hospital stay and decrease health-care costs. However, postoperative pain management is still problematic after this operation.
Post-operative pain control with the optimization of the analgesia protocol is a key aspect to be addressed to reduce the need for opioid analgesics, to quicken recovery and mobilisation, and to decrease the hospitalization length. To this regard, steroid supplementation is considered effective in decreasing post-operative pain. A recent meta-analysis from our research group on patients with total knee prosthesis proved the efficacy in decreasing post-operative pain. Moreover, a positive effect has been documented in terms of lower incidence of nausea and vomit, less post-operative range of motion limitation, and decreased systemic inflammatory response. All these benefits produced a shortened length of hospital stay without an increased risk of complications such as local infections.
Despite this overall positive effect of steroid supplementation, and their use by other specialties - e.g. anaesthesiology - and while there is now good evidence about the benefits of periarticular hip analgesic injection, e.g. FANS, opioid etc., there is still lacking evidence on the efficacy of periarticular corticosteroids in patients undergoing hip prosthetic replacement. In fact, there is a lack of information in the literature on their effectiveness in terms of pain management and function recovery. Furthermore, the influence of perioperative steroid application on the long-term follow-up results is poorly explored. This is a key issue, since the intensity of acute post-operative pain has been widely related to the risk of developing chronic post-operative pain, and thus the advantages of steroid supplementation, could go beyond the short-term pain relief and be even longer lasting.
This randomized controlled trial will thus investigate the benefit of implementing the peri-operative analgesia protocol not only to improve the acute post-operative recovery and shorten the hospital stay, but also to optimize the overall results after hip endoprosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Experimental | Drug: Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)Patient in this group will receive administration of 9 mg dexamethasone injected in the peri-articular tissues after the bone cut for hip endoprosthesis |
| Routine care | No intervention | –In this group only routinely performed anaesthesia protocol will be provided |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)Also: MephamesonDexamethasone 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) | Drug | Dexamethasone group |
Primary outcome
Postoperative pain
Time frame: 3 days after surgery
The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)
11 secondary outcomes
Hip pain and function on a numeric rating scale (NRS)
Time frame: Up to 24 months
Hip pain, function and quality of life on Harris Hip Score
Time frame: Up to 24 months
Hip pain, function and quality of life on EQ-5D-5L Score
Time frame: Up to 24 months
PainDETECT
Time frame: Up to 24 months
Nausea
Time frame: 3 days after surgery
Opioids and analgesic
Time frame: Up to 24 months
PCR & ESR
Time frame: 3 days after surgery
Mobilization
Time frame: Up to week 2
Length of hospital stay
Time frame: Up to week 2
Patient Satisfaction
Time frame: reported on a 0-10 NRS at 2 and 6 weeks, 3, 6, 12, 24 months
Hip ROM
Time frame: evaluation of range of motion preoperatively, at discharge and at 2 and 6 weeks, and at 3, 6, 12, 24 months postoperatively.
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Christian MD Candrian, Prof. principal investigator
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml) in people with Femoral Neck Fractures, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 13 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 9 Sep 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Christian MD Candrian, Prof. (0041918117029, Gabriela.Induni-Lang@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 3 days after surgery). 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 9 Sep 2026.