About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contraindications to steroids
Revision endoprosthesis
Active steroid or immunosuppressive therapy in the last 30 days before the operation
Pregnant or breast-feeding women
Trial design
Parallel
Treatments tested in this trial
Dexamethasone is a steroid drug and will be administered as an injectable solution (4mg/ml)
DrugDexamethasone 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)
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain
The mean post-operative daily pain in the first three days after surgery assessed with the 0-10 numeric rating scale (NRS)
Secondary outcomes
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
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.
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
PainDETECT
PainDETECT questionnaire for identifying neuropathic pain component and patient satisfaction on a two-level scale at 6, 12, 24 months
Sponsors and contacts
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