Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Recruiting

CT.gov ID

NCT04317872

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis Avascular Necrosis of Hip	Drug: High dose of peri-operative intravenous dexamethasone Drug: Low dose of peri-operative intravenous dexamethasone	N/A

Detailed Description

Patients listed for a direct anterior total hip arthroplasty by a single surgeon will be recruited for this study and allocated to one of two groups:

intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later
control group: 5 grams of iv dexamethasone at induction followed by placebo 12 hours later Both patients and surgeons will be blinded. Primary outcome measure will be number of steps during the first 6 weeks as measured by a pedometer. Secondary outcome measures will be side effects, complications, Patient Reported Outcome Measures, pain, nausea, stiffness, achievement of clinical milestones and use of analgesia/anti-emetics. This data will be collected using a tailor made application for a smartphone or tablet and data collecting will start one week before surgery until 6 weeks after surgery.

Based on a power analysis both groups will consist of 35 patients each.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, single surgeon, placebo controlled, double blind study using two parallel study groupsA randomized, single surgeon, placebo controlled, double blind study using two parallel study groups

Masking:

Double (Participant, Care Provider)

Masking Description:

An anesthetist or study nurse not involved in further care of the patient nor in the study will prepare the medication to administered based on the allocated group. The first syringe with either 5 or 25 mg of Aacidexam will be administered during induction. The second syringe will go with the patient to the ward and will be administered 12 hours after the surgery by the (blinded) ward nurse. The patient will not be made aware of what has been administered.

Primary Purpose:

Supportive Care

Official Title:

Do Peri-operative High Doses of Intravenous Glucocorticoids Improve Short-term Functional Outcome After Direct Anterior Total Hip Arthroplasty? A Randomized, Single Surgeon, Placebo Controlled, Double Blind Study

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Current protocol "Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.	Drug: High dose of peri-operative intravenous dexamethasone 25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours Other Names: Aacidexam
Active Comparator: Old protocol "Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).	Drug: Low dose of peri-operative intravenous dexamethasone 10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours Other Names: Aacidexam

Arm

Intervention/Treatment

Experimental: Current protocol

"Current protocol": patients will receive a single shot of 25mg of aacidexam iv (5cc) at induction. After 12 hours these patients will another shot of 10mg of aacidexam iv (2cc) on the ward.

Drug: High dose of peri-operative intravenous dexamethasone

25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours

Other Names:

Aacidexam

Active Comparator: Old protocol

"Old protocol": patients will receive a single shot of 5mg of aacidexam iv at induction (5cc). After arrival 12 hours these patients will receive a placebo, i.e. a shot of 2 cc of NaCl 0.9% iv (Mini-Plasco van B. Braun).

Drug: Low dose of peri-operative intravenous dexamethasone

10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours

Other Names:

Aacidexam

Outcome Measures

Primary Outcome Measures

Steps [6 weeks]
Number of steps as measured by a pedometer

Secondary Outcome Measures

Post-operative nausea and vomiting [up to 1 week, 0-10, lower scores indicate better clinical outcome]
Post-operative nausea and vomiting Visual Analogue Scale scores
Same day mobilization [1 day (yes or no)]
Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
Clinical milestones [6 weeks]
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Oxford Hip Score [6 weeks]
Patients Reported Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index [6 weeks]
Patients Reported Outcome Measures
Hip dysfunction and Osteoarthritis Outcome Score [6 weeks]
Patients Reported Outcome Measures
Forgotten Joint Score [6 weeks]
Patients Reported Outcome Measures
Short Form 36 [6 weeks]
Patients Reported Outcome Measures
Fatigue Severity Scale [6 weeks]
Patients Reported Outcome Measures
Groningen Activity Restriction Scale [6 weeks]
Patients Reported Outcome Measures
Pain scores [6 weeks, 0-10, lower scores indicate better clinical outcome]
Visual Analogue Scale scores during the day, the night and during exercises
Stiffness [6 weeks, 0-10, lower scores indicate better clinical outcome]
Visual Analogue Scale scores
Use of Analgesia [6 weeks]
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Use of Anti-emetics [Up to 1 week]
The use anti-emetics to reduce direct post-operative nausea
Complications [6 weeks]
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Side effects [6 weeks]
The occurrence of side-effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients undergoing unilateral uncemented THA for primary OA or AVN of the hip under general anesthesia (GA)
Aged 18 years and above (including women of child bearing age)
Able to provide informed consent