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

Primary Purpose

Coxarthrosis, Avascular Necrosis of Hip

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
High dose of peri-operative intravenous dexamethasone
Low dose of peri-operative intravenous dexamethasone
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coxarthrosis focused on measuring Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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 or 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 complications such as periprosthetic fracture

Sites / Locations

  • University Hospitals of LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Current protocol

Old protocol

Arm Description

"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.

"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).

Outcomes

Primary Outcome Measures

Steps
Number of steps as measured by a pedometer

Secondary Outcome Measures

Post-operative nausea and vomiting
Post-operative nausea and vomiting Visual Analogue Scale scores
Same day mobilization
Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
Clinical milestones
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Oxford Hip Score
Patients Reported Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index
Patients Reported Outcome Measures
Hip dysfunction and Osteoarthritis Outcome Score
Patients Reported Outcome Measures
Forgotten Joint Score
Patients Reported Outcome Measures
Short Form 36
Patients Reported Outcome Measures
Fatigue Severity Scale
Patients Reported Outcome Measures
Groningen Activity Restriction Scale
Patients Reported Outcome Measures
Pain scores
Visual Analogue Scale scores during the day, the night and during exercises
Stiffness
Visual Analogue Scale scores
Use of Analgesia
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Use of Anti-emetics
The use anti-emetics to reduce direct post-operative nausea
Complications
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Side effects
The occurrence of side-effects

Full Information

First Posted
March 17, 2020
Last Updated
October 3, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04317872
Brief Title
Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
Acronym
DEXA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis, Avascular Necrosis of Hip
Keywords
Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Current protocol
Arm Type
Experimental
Arm Description
"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.
Arm Title
Old protocol
Arm Type
Active Comparator
Arm Description
"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).
Intervention Type
Drug
Intervention Name(s)
High dose of peri-operative intravenous dexamethasone
Other Intervention Name(s)
Aacidexam
Intervention Description
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Intervention Type
Drug
Intervention Name(s)
Low dose of peri-operative intravenous dexamethasone
Other Intervention Name(s)
Aacidexam
Intervention Description
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
Primary Outcome Measure Information:
Title
Steps
Description
Number of steps as measured by a pedometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Post-operative nausea and vomiting
Description
Post-operative nausea and vomiting Visual Analogue Scale scores
Time Frame
up to 1 week, 0-10, lower scores indicate better clinical outcome
Title
Same day mobilization
Description
Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
Time Frame
1 day (yes or no)
Title
Clinical milestones
Description
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Time Frame
6 weeks
Title
Oxford Hip Score
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Hip dysfunction and Osteoarthritis Outcome Score
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Forgotten Joint Score
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Short Form 36
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Fatigue Severity Scale
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Groningen Activity Restriction Scale
Description
Patients Reported Outcome Measures
Time Frame
6 weeks
Title
Pain scores
Description
Visual Analogue Scale scores during the day, the night and during exercises
Time Frame
6 weeks, 0-10, lower scores indicate better clinical outcome
Title
Stiffness
Description
Visual Analogue Scale scores
Time Frame
6 weeks, 0-10, lower scores indicate better clinical outcome
Title
Use of Analgesia
Description
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Time Frame
6 weeks
Title
Use of Anti-emetics
Description
The use anti-emetics to reduce direct post-operative nausea
Time Frame
Up to 1 week
Title
Complications
Description
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Time Frame
6 weeks
Title
Side effects
Description
The occurrence of side-effects
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 or 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 complications such as periprosthetic fracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stijn Ghijselings, MD
Phone
+320472576735
Email
stijn.ghijselings@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Georges Vles, MD, PhD
Phone
0642180322
Ext
016340888
Email
georges.vles@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stijn Ghijselings, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges Vles, MD, PhD
Email
georges.vles@uzleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA

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