Anterior Cruciate Ligament (ACL) TearsPhase 2AAANCT01692756
Early Treatment for Acute ACL Tear
A Phase 2 study testing Kenalog in people with Anterior Cruciate Ligament (ACL) Tears, run by Cale Jacobs at 1 site in United States.
Trial summary
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. Read more about this study
- Who is it for?
- Ages 14 to 33 years
- Conditions the study is for
- Anterior Cruciate Ligament (ACL) Tears
- What is being tested?
- Kenalog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 5 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 33 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- currently participating in sporting activities
- Normal contralateral knee status
- Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity
Who cannot join
- underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)
- have been diagnosed with hepatitis B or tuberculosis
- currently have an infection, including infection of the skin
- have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
- other major medical condition requiring treatment with immunosuppressant or modulating drugs.
- A history of chronic use of non-steroidal anti-inflammatory drugs
Show all 9Show fewer
- previous exposure or allergic reaction to Kenalog
- prior knee surgery (Ipsilateral or contralateral)
- have received any investigational drug with 4 weeks of study Visit 1
Trial locations and contacts
1 site in 1 country.
United States1 site
UK HeathCare Sports Medicine
Lexington, Kentucky, 40517
About this study
Official title: Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.
The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.
Read the detailed description
Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.
In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.
- Conditions
- Anterior Cruciate Ligament (ACL) Tears
- Being tested
- Kenalog or placebo, Kenalog then Placebo, Kenalog, Placebo
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kenalog or placeboDrug
Also called Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog)
Kenalog then PlaceboDrug
Also called Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog)
KenalogDrug
Also called Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension
PlaceboDrug
Also called Drug Placebo (for Kenalog), physiologic saline solution
| Study group | Role | What they receive |
|---|---|---|
| Kenalog or Placebo | Experimental | Kenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. Receives: Drug: Kenalog or placebo |
| Kenalog then placebo | Experimental | Subjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury. Receives: Drug: Kenalog then Placebo |
| Kenalog only | Experimental | Subjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® Receives: Drug: Kenalog |
| Placebo | Placebo comparator | subjects will receive two consecutive intra-articular saline placebo injections at the same time periods. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Pain Assessment
Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Secondary outcomes (12)
Efficacy of Kenalog to Alleviate Knee Pain
The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).
Measured: Up to seven days
Synovial Interleukin-1α (IL-1α) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Interleukin-1β (IL-1β) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial C-terminal Peptide II (CTXII) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Glycosaminoglycans (GAG) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
Measured: Up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startMar 2013
- Primary completion5 Feb 2017
- Study completion5 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament (ACL) TearsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cale Jacobs
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor-investigator, Cale Jacobs, University of Kentucky
- Investigators
- Christian Lattermann, MD, Principal investigator, University of Kentucky, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692756
- Sponsor's protocol ID
- 12-0706
- Acronym
- AAA
- Status last verified
- Nov 2018
- First submitted
- 11 Sep 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.
PubMed 28146402Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.
PubMed 27279368King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Cartilage. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Epub 2018 Jul 22.
PubMed 30033738
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anti-inflammatory Treatment in Patients With Acute ACL Tear
- ClinicalTrials.gov ID
- NCT01692756
- Acronym / sponsor ID
- AAA / 12-0706
- Conditions
- Anterior Cruciate Ligament (ACL) Tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Cale JacobsUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Mar 2013
- Primary completion
- 5 Feb 2017 (actual)
- Study completion
- 5 Feb 2017 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University.
The purpose of this research is to gather information on how safe and effective Kenalog® is in alleviating knee pain following ACL rupture.
Detailed description
Injury to the knee during sports participation often involves partial of full detachment of the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.
In this research study, we hope to prevent and reduce the initial post-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL injuries by treating them within 1-2 days after their injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kenalog or Placebo | Experimental | Drug: Kenalog or placeboKenalog® (40mg) or saline placebo injection 1-2 days after ACL injury and 12-14 days later. |
| Kenalog then placebo | Experimental | Drug: Kenalog then PlaceboSubjects will initially receive 40mg injection of Kenalog® 1-2 days after injury and saline placebo at 12-14 days post injury. |
| Kenalog only | Experimental | Drug: KenalogSubjects will receive two consecutive (40 mg) intra-articular injections of Kenalog® |
| Placebo | Placebo comparator | Drug: Placebosubjects will receive two consecutive intra-articular saline placebo injections at the same time periods. |
Who may qualify
- Ages
- 14 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- currently participating in sporting activities
- Normal contralateral knee status
- Anterior Cruciate Ligament (ACL) injury occurred while playing a sporting activity
Key exclusion criteria (9 listed)
- underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis, etc.)
- have been diagnosed with hepatitis B or tuberculosis
- currently have an infection, including infection of the skin
- have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
- other major medical condition requiring treatment with immunosuppressant or modulating drugs.
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 |
|---|---|---|
| Kenalog or placeboAlso: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog) | Drug | Kenalog or Placebo |
| Kenalog then PlaceboAlso: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension, Drug Placebo (for Kenalog) | Drug | Kenalog then placebo |
| KenalogAlso: Drug: Kenalog, Other Names:, triamcinolone acetonide injectable suspension | Drug | Kenalog only |
| PlaceboAlso: Drug Placebo (for Kenalog), physiologic saline solution | Drug | Placebo |
Primary outcome
Participant Pain Assessment
Time frame: Up to seven days
Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.
12 secondary outcomes
Efficacy of Kenalog to Alleviate Knee Pain
Time frame: Up to seven days
Synovial Interleukin-1α (IL-1α) Concentration
Time frame: Up to seven days
Synovial Interleukin-1β (IL-1β) Concentration
Time frame: Up to seven days
Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration
Time frame: Up to seven days
Synovial C-terminal Peptide II (CTXII) Concentration
Time frame: Up to seven days
Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration
Time frame: Up to seven days
Synovial Glycosaminoglycans (GAG) Concentration
Time frame: Up to seven days
Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration
Time frame: Up to seven days
Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration
Time frame: Up to seven days
Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration
Time frame: Up to seven days
Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration
Time frame: Up to seven days
Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration
Time frame: Up to seven days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28146402Lattermann C, Jacobs CA, Proffitt Bunnell M, Huston LJ, Gammon LG, Johnson DL, Reinke EK, Huebner JL, Kraus VB, Spindler KP. A Multicenter Study of Early Anti-inflammatory Treatment in Patients With Acute Anterior Cruciate Ligament Tear. Am J Sports Med. 2017 Feb;45(2):325-333. doi: 10.1177/0363546516666818. Epub 2016 Oct 7.
- Results publication: PubMed 27279368Lattermann C, Jacobs CA, Bunnell MP, Jochimsen KN, Abt JP, Reinke EK, Gammon LG, Huebner JL, Kraus VB, Spindler KP. Logistical challenges and design considerations for studies using acute anterior cruciate ligament injury as a potential model for early posttraumatic osteoarthritis. J Orthop Res. 2017 Mar;35(3):641-650. doi: 10.1002/jor.23329. Epub 2016 Jun 30.
- Derived from this study: PubMed 30033738King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Cartilage. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Epub 2018 Jul 22.
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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.
Christian Lattermann, MD principal investigator
University of Kentucky, Department of Orthopaedic Surgery
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 Kenalog in people with Anterior Cruciate Ligament (ACL) Tears, run by Cale Jacobs at 1 site in United States.
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 9 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 5 Dec 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participant Pain Assessment (time frame: Up to seven days). 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 NCT01692756, which also lists 3 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 5 Dec 2018.