OsteoarthrosisPhase 2/3NCT02542592
Effect of Methylprednisolone on Immune Signaling in Hip-arthroplasty Patients
A Phase 2/3 study testing Methylprednisolone and Isotonic Sodium Chloride in people with Osteoarthrosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on immune signaling and recovery after surgery. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthrosis
- What is being tested?
- Methylprednisolone and Isotonic Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to Jan 2017
- Phase
- Phase 2/3
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthrosis
- Undergoing total unilateral hip-arthroplasty surgery
- Speak and understand Danish
- Have given informed content
Who cannot join
- Revision or bilateral hip-arthroplasty surgery
- General anaesthesia
- Allergy or intolerance towards Methylprednisolone
- Local or systemic infection
- Permanent systemic treatment with steroids within 30 days peroperatively
- Insulin-dependent diabetes
Show all 15Show fewer
- Atrial fibrillation
- Neurological disease incl. Parkinsons
- Daily use of hypnotics or sedatives
- Alcohol abuse >35 units per week
- Active treatment of ulcer within 3 months preoperatively
- Cancer disease
- Autoimmune disease incl. rheumatoid arthritis
- Pregnant or breast feeding women
- Menopause <1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty
The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on immune signaling and recovery after surgery.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the group receiving Methylprednisolone will experience a positive modulation of the immune response and an enhanced recovery.
Read the detailed description
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.
Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. The many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation.
The study is to be considered as exploratory. This study is embedded in a primary study registrated as: NCT02445898
For further details please view the EudraCT registration:
EudraCT nr.: 2015-000102-19
- Conditions
- Osteoarthrosis
- Being tested
- Methylprednisolone, Isotonic Sodium Chloride
- Keywords
- Glucocorticoids, Immune Signaling, Recovery, Hip arthroplasty, total
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solu-Medrol
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Isotonic Sodium ChlorideDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Preoperative single high dose of Solu-Medrol 125 mg iv. Receives: Drug: Methylprednisolone |
| Placebo | Placebo comparator | Preoperative single dose of isotonic Sodium Chloride Receives: Drug: Isotonic Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (5)
Change in concentration of plasma-STAT3 from baseline to 14 days after surgery
Measured: 14 days after surgery
Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery
Measured: 14 days after surgery
Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery
Measured: 14 days after surgery
Change in Surgical Recovery Scale score from baseline to 28 days after surgery
Measured: 28 days after surgery
Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthrosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Viktoria Oline Lindberg-Larsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Viktoria Lindberg-Larsen, MD, Principal investigator, Section for Surgical Pathophysiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542592
- Sponsor's protocol ID
- HK_VL_08_2015a
- Other IDs
- 2015-000102-19, 2015
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2015
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoecklein VM, Osuka A, Lederer JA. Trauma equals danger--damage control by the immune system. J Leukoc Biol. 2012 Sep;92(3):539-51. doi: 10.1189/jlb.0212072. Epub 2012 May 31.
PubMed 22654121Wilmore DW. From Cuthbertson to fast-track surgery: 70 years of progress in reducing stress in surgical patients. Ann Surg. 2002 Nov;236(5):643-8. doi: 10.1097/00000658-200211000-00015.
PubMed 12409671Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
PubMed 1393463Giannoudis PV, Smith RM, Perry SL, Windsor AJ, Dickson RA, Bellamy MC. Immediate IL-10 expression following major orthopaedic trauma: relationship to anti-inflammatory response and subsequent development of sepsis. Intensive Care Med. 2000 Aug;26(8):1076-81. doi: 10.1007/s001340051320.
PubMed 11030163Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
PubMed 25253674Ganio EA, Stanley N, Lindberg-Larsen V, Einhaus J, Tsai AS, Verdonk F, Culos A, Ghaemi S, Rumer KK, Stelzer IA, Gaudilliere D, Tsai E, Fallahzadeh R, Choisy B, Kehlet H, Aghaeepour N, Angst MS, Gaudilliere B. Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma. Nat Commun. 2020 Jul 27;11(1):3737. doi: 10.1038/s41467-020-17565-y.
PubMed 32719355
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Intravenous High Dose Methylprednisolone on Immune Signaling in Patients Scheduled for Total Hip-arthroplasty
- ClinicalTrials.gov ID
- NCT02542592
- Acronym / sponsor ID
- HK_VL_08_2015a
- Conditions
- Osteoarthrosis
- Keywords
- Glucocorticoids, Immune Signaling, Recovery, Hip arthroplasty, total
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Sep 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
The study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total hip-arthroplasty (THA) surgery. The investigators examine the effect on immune signaling and recovery after surgery.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.
The investigators hypothesize that the group receiving Methylprednisolone will experience a positive modulation of the immune response and an enhanced recovery.
Detailed description
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.
Hip-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The basic physiological mechanisms behind restoration of recovery after surgery are still unresolved. The many different immune cells involved in the complex signal response enables wound healing and recovery, and the individual immune signal pattern might be able to predict recovery. The effects of glucocorticoids on this immune signal pattern is unknown and calls for further investigation.
The study is to be considered as exploratory. This study is embedded in a primary study registrated as: NCT02445898
For further details please view the EudraCT registration:
EudraCT nr.: 2015-000102-19
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: MethylprednisolonePreoperative single high dose of Solu-Medrol 125 mg iv. |
| Placebo | Placebo comparator | Drug: Isotonic Sodium ChloridePreoperative single dose of isotonic Sodium Chloride |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthrosis
- Undergoing total unilateral hip-arthroplasty surgery
- Speak and understand Danish
- Have given informed content
Key exclusion criteria (15 listed)
- Revision or bilateral hip-arthroplasty surgery
- General anaesthesia
- Allergy or intolerance towards Methylprednisolone
- Local or systemic infection
- Permanent systemic treatment with steroids within 30 days peroperatively
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 |
|---|---|---|
| MethylprednisoloneAlso: Solu-MedrolComparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo) | Drug | Methylprednisolone |
| Isotonic Sodium ChlorideAlso: PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery
Time frame: 48 hours after surgery
5 secondary outcomes
Change in concentration of plasma-STAT3 from baseline to 14 days after surgery
Time frame: 14 days after surgery
Change in concentration of plasma-CREB (Adenosine 3',5'-monophosphate response element-binding protein) from baseline to 14 days after surgery
Time frame: 14 days after surgery
Change in concentration of plasma-NF-kB (Nuclear factor kB) from baseline to 14 days after surgery
Time frame: 14 days after surgery
Change in Surgical Recovery Scale score from baseline to 28 days after surgery
Time frame: 28 days after surgery
Change in modified WOMAC (Western Ontario and McMaster Universities Arthritis Index) score from baseline to 28 days after surgery
Time frame: 28 days after surgery
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 18 Jan 2017.
- Background: PubMed 22654121Stoecklein VM, Osuka A, Lederer JA. Trauma equals danger--damage control by the immune system. J Leukoc Biol. 2012 Sep;92(3):539-51. doi: 10.1189/jlb.0212072. Epub 2012 May 31.
- Background: PubMed 12409671Wilmore DW. From Cuthbertson to fast-track surgery: 70 years of progress in reducing stress in surgical patients. Ann Surg. 2002 Nov;236(5):643-8. doi: 10.1097/00000658-200211000-00015.
- Background: PubMed 1393463Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.
- Background: PubMed 11030163Giannoudis PV, Smith RM, Perry SL, Windsor AJ, Dickson RA, Bellamy MC. Immediate IL-10 expression following major orthopaedic trauma: relationship to anti-inflammatory response and subsequent development of sepsis. Intensive Care Med. 2000 Aug;26(8):1076-81. doi: 10.1007/s001340051320.
- Results publication: PubMed 25253674Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
- Derived from this study: PubMed 32719355Ganio EA, Stanley N, Lindberg-Larsen V, Einhaus J, Tsai AS, Verdonk F, Culos A, Ghaemi S, Rumer KK, Stelzer IA, Gaudilliere D, Tsai E, Fallahzadeh R, Choisy B, Kehlet H, Aghaeepour N, Angst MS, Gaudilliere B. Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma. Nat Commun. 2020 Jul 27;11(1):3737. doi: 10.1038/s41467-020-17565-y.
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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.
Viktoria Lindberg-Larsen, MD principal investigator
Section for Surgical Pathophysiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylprednisolone and Isotonic Sodium Chloride in people with Osteoarthrosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 15 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 18 Jan 2017. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in concentration of plasma-STAT3 (Signal transducer and activator of transcription) from baseline to 48 hours after surgery (time frame: 48 hours after surgery). 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 NCT02542592, which also lists 6 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 18 Jan 2017.