LOSPhase 4NCT00968903
Effects of Methylprednisolone After Total Hip Arthroplasty
A Phase 4 study testing Methylprednisolone in people with LOS and Postoperative Pain, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty. The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LOS, Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Jan 2011
- Phase
- Phase 4
- 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
- Elective total hip arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Who cannot join
- Alcohol or medical abuse
- Allergies to local anesthetics or methylprednisolone
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding (fertile women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.
Read the detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.
- Conditions
- LOS, Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
- Being tested
- Methylprednisolone
- Keywords
- Hip arthroplasty, Methylprednisolone, Post-operative pain
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 125 mg iv pre-operatively
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Active comparator | Methylprednisolone 125 mg iv pre-operatively Receives: Drug: Methylprednisolone |
| Saline | Placebo comparator | Saline iv pre-operatively in equivalent volume (placebo) Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fulfill discharge criteria
Measured: At discharge (mean 1-2 days)
Secondary outcomes (8)
Hand muscle strength
Measured: 24 hours
Sleeping quality on the visual analog scale
Measured: up to four days
Inflammatory response measured as CRP in blood sample
Measured: 24 hours postoperatively
Fatigue measured on a 10 point numeric range scale
Measured: up to four days
Additional analgetics, antinausea agents and sleeping medicine.
Measures as mg (analgetics) and daily use (yes or no)(antinausea agents and sleeping medicine).
Measured: up to four days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 30 days
Postoperative pain scores on the visual analog scale
Measured: up 30 days
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LOSStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968903
- Sponsor's protocol ID
- H-A-2008-030
- Other IDs
- 2009-41-3784, 2612-3916, EudraCT: 2008-006528-67
- Status last verified
- Sep 2011
- First submitted
- 28 Aug 2009
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT00968903
- Acronym / sponsor ID
- H-A-2008-030
- Conditions
- LOS, Postoperative Pain, Postoperative Nausea and Vomiting, Sleeping Quality, Fatigue, Inflammatory Response
- Keywords
- Hip arthroplasty, Methylprednisolone, Post-operative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Aug 2009 (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 purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.
The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.
Detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.
Study design
- Primary purpose
- Supportive care
- 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: MethylprednisoloneMethylprednisolone 125 mg iv pre-operatively |
| Saline | Placebo comparator | Drug: MethylprednisoloneSaline iv pre-operatively in equivalent volume (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective total hip arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Key exclusion criteria (5 listed)
- Alcohol or medical abuse
- Allergies to local anesthetics or methylprednisolone
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding (fertile women)
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 |
|---|---|---|
| MethylprednisoloneMethylprednisolone 125 mg iv pre-operatively | Drug | Methylprednisolone, Saline |
Primary outcome
Time to fulfill discharge criteria
Time frame: At discharge (mean 1-2 days)
8 secondary outcomes
Hand muscle strength
Time frame: 24 hours
Sleeping quality on the visual analog scale
Time frame: up to four days
Inflammatory response measured as CRP in blood sample
Time frame: 24 hours postoperatively
Fatigue measured on a 10 point numeric range scale
Time frame: up to four days
Additional analgetics, antinausea agents and sleeping medicine.
Time frame: up to four days
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 30 days
Postoperative pain scores on the visual analog scale
Time frame: up 30 days
Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
Time frame: up to 4 days
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 29 Sep 2011.
Related trials for LOS
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
Presbyopia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone in people with LOS and Postoperative Pain, run by Hvidovre University Hospital 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 3 inclusion and 5 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 29 Sep 2011. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to fulfill discharge criteria (time frame: At discharge (mean 1-2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2011.