Clinical trial • Phase IV • Musculoskeletal

BETAMETHASONE SODIUM PHOSPHATE for Postoperative lower limb edema | Primary hip osteoarthritis

Phase IV trial of BETAMETHASONE SODIUM PHOSPHATE for Postoperative lower limb edema | Primary hip osteoarthritis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Postoperative lower limb edema | Primary hip osteoarthritis
Trial Stage
Phase IV
Drug Modality
Small molecule|Small molecule

Key dates

Initial CTIS Submission Date
18-10-2024
First CTIS Authorization Date
21-10-2024

Trial design

Randomised, intervention arm: single dose of dexamethasone 0.2 mg/kg (equivalent to 0.05 ml/kg of the pharmacy preparation 20 mg/5 ml), diluted by nursing staff in the operating room in 500 ml of saline solution. control arm: single dose placebo consisting of 0.05 ml/kg of the syringe prepared with saline (sf), diluted by nursing staff in the operating room in 500 ml of saline solution. Phase IV trial across 2 sites in Spain.

Randomised
Yes
Comparator
Intervention arm: single dose of dexamethasone 0.2 mg/kg (equivalent to 0.05 ml/kg of the pharmacy preparation 20 mg/5 ml), diluted by nursing staff in the operating room in 500 ml of saline solution. Control arm: single dose placebo consisting of 0.05 ml/kg of the syringe prepared with saline (SF), diluted by nursing staff in the operating room in 500 ml of saline solution.
Target Sample Size
62

Eligibility

Recruits 62 No vulnerable population selected; study population is adults aged 30-80. Participants must accept and sign informed consent. Subject information and informed consent form (adult) is provided (L1_SIS and ICF adult). No assent process for minors is described..

Vulnerable Population
No vulnerable population selected; study population is adults aged 30-80. Participants must accept and sign informed consent. Subject information and informed consent form (adult) is provided (L1_SIS and ICF adult). No assent process for minors is described.

Inclusion criteria

  • {"criterion_text":"- Men and women aged 30-80 years"}
  • {"criterion_text":"- Patients that undergo primary total hip replacement"}
  • {"criterion_text":"- Diagnosis of primary hip osteoarthritis"}
  • {"criterion_text":"- Accept and sign the informed consent"}

Exclusion criteria

  • {"criterion_text":"- Patient undergoing corticosteroid treatment during the last 6 months before surgery"}
  • {"criterion_text":"- Patients with a diagnosis of secondary osteoarthritis of the hip"}
  • {"criterion_text":"- Patients with a diagnosis of hip fracture"}
  • {"criterion_text":"- Allergic patients to Dexamethasone"}
  • {"criterion_text":"- Patients who meet the criteria for malnutrition"}
  • {"criterion_text":"- Patient with a diagnosis of Diabetes Mellitus (DM1 and DM2)"}
  • {"criterion_text":"- Patients with Congestive Heart Failure (CHF)"}
  • {"criterion_text":"- Patients with Chronic Renal Insufficiency (eGFR<60)."}
  • {"criterion_text":"- Patients with peripheral venous insufficiency"}
  • {"criterion_text":"- Patients diagnosed with previous lymphedema"}
  • {"criterion_text":"- Patients with alterations of the cortico-adrenal axis"}
  • {"criterion_text":"- Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Thigh circumference • Leg Perimeter • PCR value • IL-6 value","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- sex Age Body mass index Medical history Type of approach Physiotherapy start day Time of admission Postoperative visual analog scale (VAS) • Harris Functional Scale (HHS)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
62
Recruitment Window Months
60
Consent Approach
Adults (30-80 years) must accept and sign the informed consent. A subject information sheet and adult informed consent form (L1_SIS and ICF adult) are provided. Documents/translations include Spanish. No assent for minors is described.

Geography

Total Number Of Sites
2
Total Number Of Participants
62

Spain

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
21-10-2024
Processing Time Days
7
Number Of Sites
2
Number Of Participants
62

Sites

Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Cirugia Ortopedica y Traumatologia
Principal Investigator Name
Josep Dellonder
Principal Investigator Email
jdellonder.girona.ics@gencat.cat
Contact Person Name
Josep Dellonder
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cirugia Ortopedica y Traumatologia
Principal Investigator Name
Alejandro Hernandez
Principal Investigator Email
alesherna@gmail.com
Contact Person Name
Alejandro Hernandez
Contact Person Email
alesherna@gmail.com

Sponsor

Primary sponsor

Full Name
Hospital Universitari De Girona Doctor Josep Trueta
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
DEXAMETHASONE
Active Substance
BETAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous (infusion), diluted in 500 ml saline
Starting Dose
0.2 mg/Kg (single dose; equivalent to 0.05 ml/kg of the pharmacy preparation 20 mg/5 ml)
Dose Levels
0.2 mg/Kg
Frequency
Single dose
Maximum Dose
0.2 mg/Kg
Investigational Product Name
SODIUM CHLORIDE (Saline solution, placebo)
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous (infusion), diluted in 500 ml saline
Starting Dose
0.05 ml/kg (single dose placebo syringe), diluted in 500 ml saline
Dose Levels
0.05 ml/kg
Frequency
Single dose
Maximum Dose
5 ml

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