Knee InjuriesPhase 4NCT01997138
Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy
A Phase 4 study testing Anakinra 100 mg in 2 ml saline IA in people with Knee Injuries, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Anakinra 100 mg in 2 ml saline IA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
- Being informed about and willing to participate in the study -
Who cannot join
- Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
- Established osteoarthritis or synovitis
- Known intolerance to anakinra
- Kidney failure (Creatinine clearance <30ml/min)
- History of frequent infectious diseases or immunodeficiency
- Heart failure
Show all 12Show fewer
- History of drug -or alcohol abuse
- Participation in other synchronous clinical trials
- Perioperative steroid treatment, perioperative paracetamol (12 hrs), NSAIDs (24 hrs) or COX2-inhibitors (48 hrs).
- Use of tourniquet for bloodless field
- Strong preoperative pain (VRS ≥3)
- Intolerable postoperative pain (VRS=4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique
This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.
Read the detailed description
The effects of the recombinant IL-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. On inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). VAS scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. The patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). The patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.
- Conditions
- Knee Injuries
- Being tested
- Anakinra 100 mg in 2 ml saline IA
- Keywords
- pain, inflammation, surgery
- Medical subject headings
- Knee Injuries, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra 100 mg in 2 ml saline IADrug
Also called Kineret
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Anakinra 100 mg in 2 ml saline IA Receives: Drug: Anakinra 100 mg in 2 ml saline IA |
| Placebo | Placebo comparator | Saline 2 ml IA Receives: Drug: Anakinra 100 mg in 2 ml saline IA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Selv reported pain
Measured: 72h
Secondary outcomes (1)
Resuce analgesic drug consumption
Need for and consumption of resuce analgesic drug
Measured: 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMar 2016
- Primary completionJan 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Too few recruitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital
- Responsible party
- Principal investigator, Leiv Arne Rosseland, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997138
- Sponsor's protocol ID
- anakinrapain1
- Status last verified
- Jun 2021
- First submitted
- 22 Nov 2013
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraarticular IL1-Ra on Pain and Inflammatory Mediators After Knee Arhroscopy -a Double Blind, Placebo Controlled Study Using Microdialysis Technique
- ClinicalTrials.gov ID
- NCT01997138
- Acronym / sponsor ID
- anakinrapain1
- Conditions
- Knee Injuries
- Keywords
- pain, inflammation, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too few recruitable patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Lovisenberg Diakonale Hospital
- Study start
- Mar 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Nov 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.
This project investigates the relation between acute pain and local inflammation. Pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. Patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.
Detailed description
The effects of the recombinant IL-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. On inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). VAS scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. The patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). The patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: Anakinra 100 mg in 2 ml saline IAAnakinra 100 mg in 2 ml saline IA |
| Placebo | Placebo comparator | Drug: Anakinra 100 mg in 2 ml saline IASaline 2 ml IA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Otherwise healthy patients (ASA 1 and 2) undergoing knee arthroscopy in general anaesthesia.
- Being informed about and willing to participate in the study -
Key exclusion criteria (12 listed)
- Pregnancy or lactation. Fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt.
- Established osteoarthritis or synovitis
- Known intolerance to anakinra
- Kidney failure (Creatinine clearance <30ml/min)
- History of frequent infectious diseases or 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 |
|---|---|---|
| Anakinra 100 mg in 2 ml saline IAAlso: Kineret | Drug | Anakinra, Placebo |
Primary outcome
Pain relief
Time frame: 72h
Selv reported pain
1 secondary outcome
Resuce analgesic drug consumption
Time frame: 72h
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 11 Jun 2021.
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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 4 study testing Anakinra 100 mg in 2 ml saline IA in people with Knee Injuries, run by Oslo University Hospital at 1 site in Norway.
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 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: withdrawn, as of the sponsor's last update on 11 Jun 2021. 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 Norway. 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 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?
Pain relief (time frame: 72h). 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 11 Jun 2021.