Functional recovary after total hip arthroplasty
Conditions
Interventions
Trade Name: Aacidexam
Product Name: Aacidexam
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - All patients undergoing unilateral uncemented THA for primary OA of AVN of the hip under general anesthesia (GA) - Aged 18 years and above (including women of child bearing age) - Able to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Younger than 18 years - Known alcohol or drug abuse - Known allergy for glucocorticoids - Administration of any glucocorticoids in the last three months - Usage of strong analgesia (such as lyrica, oxycodone) as regular medication - Usage of medication with anticipated interactions with glucocorticoids - Known gastric ulcer - Insulin dependent diabetes mellitus - Severe heart disease (NYHA > 2) - Liver or renal failure - Systemic rheumatoid diseases - Insufficient understanding of the Dutch language - Unable to provide informed consent - Pre-operative use of walking aids - Gross anatomical deformities - Significant intra-operative complication such as peri-prosthetic fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether peri-operative intravenous glucocorticoids aid in the recovery after THA.;Secondary Objective: Post-operative nausea and vomiting (PONV) Same day mobilization Time to ability to do stairs Time to driving a car Patient questionnaires: Oxford Hip Score; WOMAC; HOOS; Forgotten Joint Score; SF-36; Fatigue Severity scale; VAS pain day / night / exercises; VAS stiffness Use of analgesia Use of anti-emetics Complications: wound healing problems; Infections; allergic reactions; venous Trombo-embolisms (VTE); side effects ;Primary end point(s): Average number of steps ;Timepoint(s) of evaluation of this end point: Average number of steps per day during one week before total hip arthroplastyand the first 6 weeks after total hip arthroplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Post-operative nausea and vomiting Same day mobilization Time to ability to do stairs Time to driving a car Patient questionnaires: Oxford Hip Score; WOMAC; HOOS; Forgotten Joint Score; SF-36; Fatigue Severity Scale; VAS pain day / night / exercises; VAS stiffness Use of analgesia Use of anti-emetics Complications :Wound healing problems; Infections; Allergic reactions; Venous Trombo-embolisms (VTE) ;Timepoint(s) of evaluation of this end point: Post-operative nausea and vomiting: after surgery day 0, day 1, day 2, day 3, day 4, day 5 Same day mobilization: after surgery day 0 Time to ability to do stairs: day 0, day 1, day 2, day 3, day 4, day 5, day 6, day 7 Time to driving a car: Patient questionnaires: Oxford Hip Score; WOMAC; HOOS; Forgotten Joint Score; EQ 5D; Fatigue Severity Scale; VAS pain day / night / exercises; VAS stiffness Use of analgesia: Use of anti-emetics Complications :Wound healing problems; Infections; Allergic reactions; Venous Trombo-embolisms (VTE) | — |
Countries
Belgium
Contacts
Public ContactStijn Ghijselings
University hospital Leuven
Outcome results
None listed