Coxarthrosis Clinical Trial
— DEXAOfficial 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
NCT number | NCT04317872 |
Other study ID # | S63584 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | December 1, 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals of Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9. — View Citation
Bergeron SG, Kardash KJ, Huk OL, Zukor DJ, Antoniou J. Perioperative dexamethasone does not affect functional outcome in total hip arthroplasty. Clin Orthop Relat Res. 2009 Jun;467(6):1463-7. doi: 10.1007/s11999-009-0733-x. Epub 2009 Feb 18. — View Citation
Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071. — View Citation
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
Jiang J, Wang H, Wang Y. [Clinical study on effect of dexamethasone in preventing fat embolism syndrome after cemented hip arthroplasty]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2010 Aug;24(8):913-6. Chinese. — View Citation
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
Koh IJ, Chang CB, Lee JH, Jeon YT, Kim TK. Preemptive low-dose dexamethasone reduces postoperative emesis and pain after TKA: a randomized controlled study. Clin Orthop Relat Res. 2013 Sep;471(9):3010-20. doi: 10.1007/s11999-013-3032-5. Epub 2013 May 4. — View Citation
Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7. — View Citation
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
Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to avoid? The perspective of patients. Anesth Analg. 1999 Sep;89(3):652-8. doi: 10.1097/00000539-199909000-00022. — View Citation
Marques EM, Jones HE, Elvers KT, Pyke M, Blom AW, Beswick AD. Local anaesthetic infiltration for peri-operative pain control in total hip and knee replacement: systematic review and meta-analyses of short- and long-term effectiveness. BMC Musculoskelet Disord. 2014 Jul 5;15:220. doi: 10.1186/1471-2474-15-220. — View Citation
Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23. — View Citation
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
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. — View Citation
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
Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383. — View Citation
Nanni M, Perna F, Calamelli C, Donati D, Ferrara O, Parlato A, D'Arienzo M, Faldini C. Wound drainages in total hip arthroplasty: to use or not to use? Review of the literature on current practice. Musculoskelet Surg. 2013 Aug;97(2):101-7. doi: 10.1007/s12306-013-0270-3. Epub 2013 May 25. — View Citation
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
Villatte G, Mathonnet M, Villeminot J, Savary M, Theissen A, Ostermann S, Erivan R, Raynaud-Simon A, Slim K. [Interest of enhanced recovery programs in the elderly during total hip arthroplasty A systematic review]. Geriatr Psychol Neuropsychiatr Vieil. 2019 Sep 1;17(3):234-242. doi: 10.1684/pnv.2019.0796. French. — View Citation
Xu B, Ma J, Huang Q, Huang ZY, Zhang SY, Pei FX. Erratum to: Two doses of low-dose perioperative dexamethasone improve the clinical outcome after total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc. 2018 Jun;26(6):1879. doi: 10.1007/s00167-017-4593-8. No abstract available. — View Citation
* Note: There are 27 references in all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01326832 -
10 Year Clinical Evaluation of Primoris Hip Component
|
||
Completed |
NCT02399670 -
The Influence of Global Femoral-offset Changes After Total Hip Arthroplasty
|
N/A | |
Completed |
NCT01046019 -
Measurement of Early Bone Loss Around a Total Hip Arthroplasty
|
N/A | |
Completed |
NCT00159497 -
Bone Remodeling Around HA-coated Acetabular Cups.
|
Phase 4 | |
Not yet recruiting |
NCT04570748 -
Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
|
N/A | |
Not yet recruiting |
NCT01079455 -
Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip
|
Phase 3 | |
Completed |
NCT00317889 -
Compaction Total Hip Arthroplasty (THA) Bilateral
|
N/A | |
Recruiting |
NCT04424628 -
Radiotherapy 3 vs 6 Gy in Gonarthrosis and Coxarthrosis
|
N/A | |
Not yet recruiting |
NCT06272422 -
Comparison of the Restoration of Hip Biomechanical Parameters by CT Measurement Between the 3 Surgical Techniques: RSA/Minihip/THA - Hip Replacement: 3D Planning
|
||
Completed |
NCT02694146 -
Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
|
Phase 3 | |
Completed |
NCT02719236 -
Direct Anterior Approach Versus Direct Lateral Approach in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT05343195 -
Balance and Leg Function After Hip Replacement
|
N/A | |
Completed |
NCT01279174 -
Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
|
Phase 4 | |
Active, not recruiting |
NCT00318396 -
Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
|
N/A | |
Completed |
NCT02338596 -
Ultra-Short Anatomic and Conventional Cementless Stems Cementless Stems in Patients Younger Than Fifty-Five Years Old
|
Phase 4 | |
Active, not recruiting |
NCT00722982 -
Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
|
N/A | |
Completed |
NCT04903860 -
Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement
|
N/A | |
Recruiting |
NCT03809962 -
Efficacy and Safety of Ostenil® Plus in the Treatment of Coxarthrosis
|
||
Active, not recruiting |
NCT01578746 -
Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty
|
Phase 4 | |
Completed |
NCT00317863 -
Zink and Bone Strength
|
N/A |