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

Coxarthrosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317872
• Other study ID #: S63584
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Stijn Ghijselings, MD
• Phone: +320472576735
• Email: stijn.ghijselings[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. intervention group: 25 grams of iv dexamethasone at induction followed by 10 mg of iv dexamethasone 12 hours later

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Coxarthrosis
• Necrosis
• Osteoarthritis, Hip

Intervention

Drug:
• High dose of peri-operative intravenous dexamethasone
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
• Low dose of peri-operative intravenous dexamethasone
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours

Locations

Country	Name	City	State
Belgium	University Hospitals of Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (27)

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Dissanayake R, Du HN, Robertson IK, Ogden K, Wiltshire K, Mulford JS. Does Dexamethasone Reduce Hospital Readiness for Discharge, Pain, Nausea, and Early Patient Satisfaction in Hip and Knee Arthroplasty? A Randomized, Controlled Trial. J Arthroplasty. 2018 Nov;33(11):3429-3436. doi: 10.1016/j.arth.2018.07.013. Epub 2018 Jul 19. — View Citation

Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003. — View Citation

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Kardash KJ, Sarrazin F, Tessler MJ, Velly AM. Single-dose dexamethasone reduces dynamic pain after total hip arthroplasty. Anesth Analg. 2008 Apr;106(4):1253-7, table of contents. doi: 10.1213/ANE.0b013e318164f319. — View Citation

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Lei Y, Huang Q, Xu B, Zhang S, Cao G, Pei F. Multiple Low-Dose Dexamethasone Further Improves Clinical Outcomes Following Total Hip Arthroplasty. J Arthroplasty. 2018 May;33(5):1426-1431. doi: 10.1016/j.arth.2017.11.057. Epub 2017 Dec 5. — View Citation

Lei YT, Xu B, Xie XW, Xie JW, Huang Q, Pei FX. The efficacy and safety of two low-dose peri-operative dexamethasone on pain and recovery following total hip arthroplasty: a randomized controlled trial. Int Orthop. 2018 Mar;42(3):499-505. doi: 10.1007/s00264-017-3537-8. Epub 2017 Jun 25. — View Citation

Lunn TH, Andersen LO, Kristensen BB, Husted H, Gaarn-Larsen L, Bandholm T, Ladelund S, Kehlet H. Effect of high-dose preoperative methylprednisolone on recovery after total hip arthroplasty: a randomized, double-blind, placebo-controlled trial. Br J Anaesth. 2013 Jan;110(1):66-73. doi: 10.1093/bja/aes345. Epub 2012 Sep 17. — View Citation

Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3. — View Citation

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McLawhorn AS, Beathe J, YaDeau J, Buschiazzo V, Purdue PE, Ma Y, Sculco TP, Jules-Elysee K. Effects of steroids on thrombogenic markers in patients undergoing unilateral total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Res. 2015 Mar;33(3):412-6. doi: 10.1002/jor.22776. Epub 2015 Jan 6. — View Citation

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Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1. — View Citation

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Rasmussen ML, Mathiesen O, Dierking G, Christensen BV, Hilsted KL, Larsen TK, Dahl JB. Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study. Eur J Anaesthesiol. 2010 Apr;27(4):324-30. doi: 10.1097/EJA.0b013e328331c71d. — View Citation

Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018. — View Citation

Sculco PK, Pagnano MW. Perioperative solutions for rapid recovery joint arthroplasty: get ahead and stay ahead. J Arthroplasty. 2015 Apr;30(4):518-20. doi: 10.1016/j.arth.2015.01.036. Epub 2015 Jan 30. — View Citation

Toogood PA, Abdel MP, Spear JA, Cook SM, Cook DJ, Taunton MJ. The monitoring of activity at home after total hip arthroplasty. Bone Joint J. 2016 Nov;98-B(11):1450-1454. doi: 10.1302/0301-620X.98B11.BJJ-2016-0194.R1. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

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