Infection of Total Knee Joint ProsthesisNCT02019511
Safety Study of High-dose Methylprednisolone in Fast-track Total Knee Arthroplasty
An observational study of Infection of Total Knee Joint Prosthesis, run by Copenhagen University Hospital, Rigshospitalet at 7 sites in Denmark.
Trial summary
It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection of Total Knee Joint Prosthesis
- How many people
- 0 participants
- Where
- 7 sitesDenmark
- Study dates
- Oct 2013to Oct 2016
- Phase
- Observational
- 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
Study population: Consecutive unselcted patients with unilateral elective total fast-track knee arthroplasty in a standardized perioperative set-up and with completed prospective registration of preoperative chartacteristics and co-morbidity
Who may be able to join
- Patients scheduled for primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
- Danish Social security number
Who cannot join
- One of the following contraindications for Methylprednisolone:
- Allergy against Methylprednisolone.
- Currently in systemic treatment with glucocorticoid
- Current gastric ulcer
- Insulin dependent diabetes mellitus
- Further contraindications are at the discretion of the individual department/surgeon. The cohort without preoperative Methylprednisolone treatment will be followed as a separate cohort to identify potential selection bias.
- Citizens without Danish social security number are not eligible for this study as follow-up is not possible.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Aarhus University Hospital
Aarhus, Judland, 8000
Farsoe Hospital
Farsø, Judland, 9640
Gentofte University Hospital
Gentofte Municipality
Sydvestjydsk Sygehus
Grindsted, Judland, 7200
Holstebro Hospital
Holstebro, Judland, 7500
Vejle Hospital
Vejle, Judland, 7100
Viborg Hospital
Viborg, Judland, 8800
About this study
Official title: Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Although there are some concerns about the possibility of increased risk of prosthesis infections, this has not been proved in previous studies. However the studies are few, have limited number of patients and are not done using a standardized perioperative set-up.
This study is made to monitor the safety of a single high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
Read the detailed description
In order to reduce pain intensity as much as possible after surgical procedures, modern multimodal analgesic strategies using different analgetics targeting different mechanism of the pain reception system are used. At the same time this may reduce the use of opioids, which commonly cause sideeffects such as nausea, vomiting, obstipation,urinary retention, itching, respiratory suppression and sedation.
In spite of the use of a wide perioperative multimodal analgesia, pain after total knee arthroplasty (TKA), is stil a considerable clinical problem and need for optimisation of the immediate postoperative pain treatment. There is evidence that "high"dose glucocorticoids administered preoperatively reduces the level of pain and the use of opioids after surgery. A recent review did not give cause for concern regarding use of glucocorticoids in TKA,but found that data on longterm safety aspects are lacking, why no recommendations could be made.
As the limited evidence presently points to af benefit of glucocorticoids without serious side effects, the treatment has been introduced as standard treatment in TKA at several of the departments participating in the Lundbeck Foundation Centre for fast-track Hip and Knee Replacement collaboration.
This study is made to monitor the safety of high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
- Conditions
- Infection of Total Knee Joint Prosthesis
- Keywords
- Orthopedic surgery, Infections, Steroid, Fast-track, Total knee arthroplasty, Safety
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High dose Steroid | Patients scheduled for primary unilateral elective TKA Age >17 years none of the following contraindications for Methylprednisolone: * Allergy against Methylprednisolone. * Currently in systemic treatment with glucocorticoid * Current gastric ulcer * Insulin dependent diabetes mellitus Citizens without Danish social security number are not eligible for this study as follow-up is not possible. | |
| Historical cohort | Patients having primary unilateral elective TKA before initiation of Methylprednisolone as standard treatment age >17 years, Danish social security number and none of the following at time of surgery: * systemic treatment with glucocorticoid defined as: regular prescriptions on glucocorticoid within 2 months prior to surgery. * gastric ulcer defined as: prescriptions on drugs used in "triple therapy" for Helicobacter Pylori infection or prescriptions on antiacids/proton pump inhibitors beginning 1 month before surgery * Insulin dependent diabetes mellitus defined as: any prescriptions on insulin within 6 months prior to surgery | |
| Procedures without Steroid | Patients scheduled for primary unilateral elective TKA and age >17 years but who did not receive high dose Methylprednisolone regardless of reason. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prosthesis related infections within 1 year after TKA
Causes if infection are subdivided into the following:
- Deep prosthesis related infection
- Superficial infection (defined as surgery verified infection above level of the fascia)
- Clinical / paraclinical suspicion of infection only treated with intravenous antibiotics (no surgical procedure)
- Possible infection, but no clinical/paraclinical suspicion of infection, why the patient is discharged without intravenous antibiotic treatment/surgery.
- Surgical wound revision (no clinical/paraclinical suspicion of infection)
- Surgical knee manipulation due to limited range of movement (no clinical/paraclinical suspicion of infection).
- Surgery due to aseptic non-traumatic loosening of the knee.
- Surgery due to traumatic loosening of the knee
Measured: 1 year
Secondary outcomes (4)
Frequency and cause of hospital stay >4 days
Patients admitted for >4 days will have their discharge files reviewed with regards to causes of this prolonged" stay. This in accordance with the method used in the Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement registry trials (Clinicaltrials.gov identifier:NCT01515670)
Measured: primary admission
Frequency and causes of 90 days readmissions
These will be found through review of medical files and defined as readmission possibly related to surgery and with overnight stay in hospital. These will be classified according to the method used in the ongoing trials in the Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement registry (Clin.trials ID:NCT01515670)
Measured: 90 days after surgery
Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
These will be found through review of medical files and classified appropriately into broad categories depending on data. Detailed information on each case will be recorded
Measured: 1 year
mortality
Incidence of 90 days and 1 year mortality will be reported
Measured: 90 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2016
Why it stopped: The study design was too complex regarding aquisition of registry data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Total Knee Joint ProsthesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty
- Responsible party
- Principal investigator, Christoffer Joergensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christoffer C Jørgensen, MD, Principal investigator, Section for Surgical Pathophysiology Copenhagen University, RigshospitaletTroels H Lunn, MD, PhD, Principal investigator, Section for Surgical Pathophysiology, Copenhagen University, RigshospitaletHenrik Kehlet, MD Prof PhD, Study chair, Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019511
- Sponsor's protocol ID
- RH-0703
- Status last verified
- Aug 2024
- First submitted
- 18 Dec 2013
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Aspects of High-Dose Methylprednisolone in Fast-track Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02019511
- Acronym / sponsor ID
- RH-0703
- Conditions
- Infection of Total Knee Joint Prosthesis
- Keywords
- Orthopedic surgery, Infections, Steroid, Fast-track, Total knee arthroplasty, Safety
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study design was too complex regarding aquisition of registry data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Lundbeck Foundation Centre for Fast-track Hip and Knee Arthroplasty
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Dec 2013 (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.
It has been shown that a single high dose of steroid before surgery may reduce pain the first 48 hours after insertion of a new joint in the knee, a so called "total knee arthroplasty" (TKA). Consequently, this has been introduced as standard treatment of most patients at several Danish orthopedic departments. Although there are some concerns about the possibility of increased risk of prosthesis infections, this has not been proved in previous studies. However the studies are few, have limited number of patients and are not done using a standardized perioperative set-up.
This study is made to monitor the safety of a single high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
Detailed description
In order to reduce pain intensity as much as possible after surgical procedures, modern multimodal analgesic strategies using different analgetics targeting different mechanism of the pain reception system are used. At the same time this may reduce the use of opioids, which commonly cause sideeffects such as nausea, vomiting, obstipation,urinary retention, itching, respiratory suppression and sedation.
In spite of the use of a wide perioperative multimodal analgesia, pain after total knee arthroplasty (TKA), is stil a considerable clinical problem and need for optimisation of the immediate postoperative pain treatment. There is evidence that "high"dose glucocorticoids administered preoperatively reduces the level of pain and the use of opioids after surgery. A recent review did not give cause for concern regarding use of glucocorticoids in TKA,but found that data on longterm safety aspects are lacking, why no recommendations could be made.
As the limited evidence presently points to af benefit of glucocorticoids without serious side effects, the treatment has been introduced as standard treatment in TKA at several of the departments participating in the Lundbeck Foundation Centre for fast-track Hip and Knee Replacement collaboration.
This study is made to monitor the safety of high dose steroid injection before TKA, with regards to prosthesis infection within one year of surgery.
We hypothesize that there will be no increase in infections in patients receiving steroid injection before TKA compared to a historical cohort of patents who did not receive a steroid injection before their TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose Steroid | – | –Patients scheduled for primary unilateral elective TKA Age >17 years none of the following contraindications for Methylprednisolone: * Allergy against Methylprednisolone. * Currently in systemic treatment with glucocorticoid * Current gastric ulcer * Insulin dependent diabetes mellitus Citizens without Danish social security number are not eligible for this study as follow-up is not possible. |
| Historical cohort | – | –Patients having primary unilateral elective TKA before initiation of Methylprednisolone as standard treatment age >17 years, Danish social security number and none of the following at time of surgery: * systemic treatment with glucocorticoid defined as: regular prescriptions on glucocorticoid within 2 months prior to surgery. * gastric ulcer defined as: prescriptions on drugs used in "triple therapy" for Helicobacter Pylori infection or prescriptions on antiacids/proton pump inhibitors beginning 1 month before surgery * Insulin dependent diabetes mellitus defined as: any prescriptions on insulin within 6 months prior to surgery |
| Procedures without Steroid | – | –Patients scheduled for primary unilateral elective TKA and age >17 years but who did not receive high dose Methylprednisolone regardless of reason. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive unselcted patients with unilateral elective total fast-track knee arthroplasty in a standardized perioperative set-up and with completed prospective registration of preoperative chartacteristics and co-morbidity
Key inclusion criteria (2 listed)
- Patients scheduled for primary unilateral elective TKA and no contraindications for high-dose Methylprednisolone preoperatively
- Danish Social security number
Key exclusion criteria (7 listed)
- Allergy against Methylprednisolone.
- Currently in systemic treatment with glucocorticoid
- Current gastric ulcer
- Insulin dependent diabetes mellitus
- Further contraindications are at the discretion of the individual department/surgeon. The cohort without preoperative Methylprednisolone treatment will be followed as a separate cohort to identify potential selection bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prosthesis related infections within 1 year after TKA
Time frame: 1 year
Causes if infection are subdivided into the following: 1. Deep prosthesis related infection 2. Superficial infection (defined as surgery verified infection above level of the fascia) 3. Clinical / paraclinical suspicion of infection only treated with intravenous antibiotics (no surgical procedure) 4. Possible infection, but no clinical/paraclinical suspicion of infection, why the patient is discharged without intravenous antibiotic treatment/surgery. 5. Surgical wound revision (no clinical/paraclinical suspicion of infection) 6. Surgical knee manipulation due to limited range of movement (no clinical/paraclinical suspicion of infection). 7. Surgery due to aseptic non-traumatic loosening of the knee. 8. Surgery due to traumatic loosening of the knee
4 secondary outcomes
Frequency and cause of hospital stay >4 days
Time frame: primary admission
Frequency and causes of 90 days readmissions
Time frame: 90 days after surgery
Frequencies and causes of readmissions to orthopedic departments 12 months after TKA.
Time frame: 1 year
mortality
Time frame: 90 days and 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
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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.
Christoffer C Jørgensen, MD principal investigator
Section for Surgical Pathophysiology Copenhagen University, Rigshospitalet
Troels H Lunn, MD, PhD principal investigator
Section for Surgical Pathophysiology, Copenhagen University, Rigshospitalet
Henrik Kehlet, MD Prof PhD study chair
Secton for Surgical Pathophysiology, Copenhagen University , Rigshospitalet
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection of Total Knee Joint Prosthesis, run by Copenhagen University Hospital, Rigshospitalet at 7 sites 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
prosthesis related infections within 1 year after TKA (time frame: 1 year). 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 7 Aug 2024.