Knee Joint OsteoarthrosisPhase 2NCT02253966
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
A Phase 2 study testing Methylprednisoloneacetate, Lidocaine and sodium chloride in people with Knee Joint Osteoarthrosis and Hyperalgesia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Joint Osteoarthrosis, Hyperalgesia, Severe Movement Related Pain
- What is being tested?
- Methylprednisoloneacetate, Lidocaine and sodium chloride
- 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
- Oct 2014to Mar 2016
- Phase
- Phase 2
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 -80
- Osteoarthrosis
- Scheduled for primary unilateral TKA
- Preoperative pain report with NRS > 5 upon walking
- Signs of sensitisation in knee
Who cannot join
- Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
- Deficient written or spoken danish
- Impairment from psychological or neurological disease
- Local og systemic infection
- Immunodeficiency
- Treatment with corticosteroid within 30 days of inclusion
Show all 12Show fewer
- Insulin treated diabetes mellitus
- Anticoagulant therapy
- ASA (American Society of Anaesthesia) class > 3
- General anaesthesia
- Alchohol use > 21 units / week
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.
The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.
- Being tested
- Methylprednisoloneacetate, Lidocaine, sodium chloride
- Medical subject headings
- Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylprednisoloneacetateDrug
Also called Depo-Medrol
LidocaineDrug
sodium chlorideOther
Also called saline
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisoloneacetate | Active comparator | Administration of:
1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery. Receives: Drug: Methylprednisoloneacetate; Drug: Lidocaine; Other: sodium chloride |
| Sodium chloride | Placebo comparator | Administration of:
5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery. Receives: Drug: Lidocaine; Other: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
Measured: 24 hours postoperatively
Secondary outcomes (6)
Pain
Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following
Measured: 48 hours postoperatively
Pain
Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day
Measured: From day 1 to day 14
Pain
Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day
Measured: From day 1 to day 14
Sensitisation
Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.
Measured: On day 0 and day 2
Inflammation
Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.
Measured: On day 0 and day 2
Inflammation
Measurement of interleukin-6 level in knee joint fluid on the day of surgery.
Measured: On day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Joint 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
- Primary purpose
- Prevention
- 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
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Iben Engelund Luna, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253966
- Sponsor's protocol ID
- H-3-2014-089
- Status last verified
- Jun 2016
- First submitted
- 29 Sep 2014
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
- ClinicalTrials.gov ID
- NCT02253966
- Acronym / sponsor ID
- H-3-2014-089
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Oct 2014 (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.
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.
The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisoloneacetate | Active comparator | Drug: Methylprednisoloneacetate, Drug: Lidocaine, Other: sodium chlorideAdministration of: 1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery. |
| Sodium chloride | Placebo comparator | Drug: Lidocaine, Other: sodium chlorideAdministration of: 5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 -80
- Osteoarthrosis
- Scheduled for primary unilateral TKA
- Preoperative pain report with NRS > 5 upon walking
- Signs of sensitisation in knee
Key exclusion criteria (12 listed)
- Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
- Deficient written or spoken danish
- Impairment from psychological or neurological disease
- Local og systemic infection
- Immunodeficiency
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 |
|---|---|---|
| MethylprednisoloneacetateAlso: Depo-Medrol | Drug | Methylprednisoloneacetate |
| Lidocaine | Drug | Methylprednisoloneacetate, Sodium chloride |
| sodium chlorideAlso: saline | Other | Methylprednisoloneacetate, Sodium chloride |
Primary outcome
Pain
Time frame: 24 hours postoperatively
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
6 secondary outcomes
Pain
Time frame: 48 hours postoperatively
Pain
Time frame: From day 1 to day 14
Pain
Time frame: From day 1 to day 14
Sensitisation
Time frame: On day 0 and day 2
Inflammation
Time frame: On day 0 and day 2
Inflammation
Time frame: On day 0
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 6 Jun 2016.
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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.
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 2 study testing Methylprednisoloneacetate, Lidocaine and sodium chloride in people with Knee Joint Osteoarthrosis and Hyperalgesia, 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 5 inclusion and 12 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 6 Jun 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain (time frame: 24 hours postoperatively). 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 6 Jun 2016.