CoxarthrosisDEXANCT04317872
Effect of Peri-operative Glucocorticoids on Short-term Functional Outcome After THA
A study testing High dose of peri-operative intravenous dexamethasone and Low dose of peri-operative intravenous dexamethasone in people with Coxarthrosis and Avascular Necrosis of Hip, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coxarthrosis, Avascular Necrosis of Hip
- What is being tested?
- High dose of peri-operative intravenous dexamethasone and Low dose of peri-operative intravenous dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Coxarthrosis, Avascular Necrosis of Hip
- Being tested
- High dose of peri-operative intravenous dexamethasone, Low dose of peri-operative intravenous dexamethasone
- Keywords
- Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose of peri-operative intravenous dexamethasoneDrug
Also called Aacidexam
25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
Low dose of peri-operative intravenous dexamethasoneDrug
Also called Aacidexam
10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Low dose of peri-operative intravenous dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps
Number of steps as measured by a pedometer
Measured: 6 weeks
Secondary outcomes (16)
Post-operative nausea and vomiting
Post-operative nausea and vomiting Visual Analogue Scale scores
Measured: up to 1 week, 0-10, lower scores indicate better clinical outcome
Same day mobilization
Whether or not if was possible for the physiotherapists to mobilize the patient on the day of surgery
Measured: 1 day (yes or no)
Clinical milestones
Time to achieve certain clinical milestones, e.g. climbing stairs, driving a car, etc
Measured: 6 weeks
Oxford Hip Score
Patients Reported Outcome Measures
Measured: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Patients Reported Outcome Measures
Measured: 6 weeks
Hip dysfunction and Osteoarthritis Outcome Score
Patients Reported Outcome Measures
Measured: 6 weeks
Forgotten Joint Score
Patients Reported Outcome Measures
Measured: 6 weeks
Short Form 36
Patients Reported Outcome Measures
Measured: 6 weeks
Fatigue Severity Scale
Patients Reported Outcome Measures
Measured: 6 weeks
Groningen Activity Restriction Scale
Patients Reported Outcome Measures
Measured: 6 weeks
Pain scores
Visual Analogue Scale scores during the day, the night and during exercises
Measured: 6 weeks, 0-10, lower scores indicate better clinical outcome
Stiffness
Visual Analogue Scale scores
Measured: 6 weeks, 0-10, lower scores indicate better clinical outcome
Use of Analgesia
The use of analgesia such as paracetamol (acetominophen), NSAIDs, and morphine(like) substances
Measured: 6 weeks
Use of Anti-emetics
The use anti-emetics to reduce direct post-operative nausea
Measured: Up to 1 week
Complications
The occurrence of complications such as wound healing problems, infections, allergic reactions, venous thrombo-embolisms, etc
Measured: 6 weeks
Side effects
The occurrence of side-effects
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Jul 2020
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stijn Ghijselings, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317872
- Sponsor's protocol ID
- S63584
- Acronym
- DEXA
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2020
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17964352Macario 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.
PubMed 10475299Marques 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.
PubMed 24996539Myles 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.
PubMed 10740539Salerno 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.
PubMed 16757774Choi 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.
PubMed 12917945Moskal 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.
PubMed 27248332Hojer 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.
PubMed 25599296Nanni 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.
PubMed 23709186Villatte 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.
PubMed 31251213Kardash 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.
PubMed 18349202Mathiesen 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.
PubMed 18653493Bergeron 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.
PubMed 19224304Rasmussen 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.
PubMed 19734790Miyagawa 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.
PubMed 21054459
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04317872
- Acronym / sponsor ID
- DEXA / S63584
- Conditions
- Coxarthrosis, Avascular Necrosis of Hip
- Keywords
- Total Hip Arthroplasty, Direct Anterior Approach, Glucocorticoids, Short term functional outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized, single surgeon, placebo controlled, double blind study using two parallel study groups
| Arm | Type | Receives |
|---|---|---|
| Current protocol | Experimental | Drug: High dose of peri-operative intravenous dexamethasone"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 | Active comparator | Drug: Low dose of peri-operative intravenous dexamethasone"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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose of peri-operative intravenous dexamethasoneAlso: Aacidexam25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours | Drug | Current protocol |
| Low dose of peri-operative intravenous dexamethasoneAlso: Aacidexam10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours | Drug | Old protocol |
Primary outcome
Steps
Time frame: 6 weeks
Number of steps as measured by a pedometer
16 secondary outcomes
Post-operative nausea and vomiting
Time frame: up to 1 week, 0-10, lower scores indicate better clinical outcome
Same day mobilization
Time frame: 1 day (yes or no)
Clinical milestones
Time frame: 6 weeks
Oxford Hip Score
Time frame: 6 weeks
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 6 weeks
Hip dysfunction and Osteoarthritis Outcome Score
Time frame: 6 weeks
Forgotten Joint Score
Time frame: 6 weeks
Short Form 36
Time frame: 6 weeks
Fatigue Severity Scale
Time frame: 6 weeks
Groningen Activity Restriction Scale
Time frame: 6 weeks
Pain scores
Time frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Stiffness
Time frame: 6 weeks, 0-10, lower scores indicate better clinical outcome
Use of Analgesia
Time frame: 6 weeks
Use of Anti-emetics
Time frame: Up to 1 week
Complications
Time frame: 6 weeks
Side effects
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 17964352Learmonth 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.
- Background: PubMed 10475299Macario 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.
- Background: PubMed 24996539Marques 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.
- Background: PubMed 10740539Myles 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.
- Background: PubMed 16757774Salerno 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.
- Background: PubMed 12917945Choi 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.
- Background: PubMed 27248332Moskal 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.
- Background: PubMed 25599296Hojer 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.
- Background: PubMed 23709186Nanni 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.
- Background: PubMed 31251213Villatte 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.
- Background: PubMed 18349202Kardash 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.
- Background: PubMed 18653493Mathiesen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn Ghijselings, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose of peri-operative intravenous dexamethasone and Low dose of peri-operative intravenous dexamethasone in people with Coxarthrosis and Avascular Necrosis of Hip, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317872, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.