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

NCT04317872 | Completed DMC

• 1 other identifier: S63584
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis; Avascular Necrosis of Hip

Keywords

Total Hip Arthroplasty; Direct Anterior Approach; Glucocorticoids; Short term functional outcome

Outcome Measures

Primary Outcomes (1)

• Steps

  Number of steps as measured by a pedometer

  6 weeks

Secondary Outcomes (16)

• Post-operative nausea and vomiting

  up to 1 week, 0-10, lower scores indicate better clinical outcome

• Same day mobilization

  1 day (yes or no)

• Clinical milestones

  6 weeks

• Oxford Hip Score

  6 weeks

• Western Ontario and McMaster Universities Osteoarthritis Index

  6 weeks

Study Arms (2)

Current protocol

EXPERIMENTAL

"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

Old protocol

ACTIVE COMPARATOR

"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

Interventions

High dose of peri-operative intravenous dexamethasone DRUG

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

Also known as: Aacidexam

Current protocol

Low dose of peri-operative intravenous dexamethasone DRUG

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

Also known as: Aacidexam

Old protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals of Leuven

Leuven, 3000, Belgium

Location

Related Publications (27)

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• Miyagawa Y, Ejiri M, Kuzuya T, Osada T, Ishiguro N, Yamada K. Methylprednisolone reduces postoperative nausea in total knee and hip arthroplasty. J Clin Pharm Ther. 2010 Dec;35(6):679-84. doi: 10.1111/j.1365-2710.2009.01141.x.

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MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Stijn Ghijselings, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 23, 2020
• Study Start: July 1, 2020
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)