Knee OsteoarthritisNOCTURN-PAINNCT03998943
NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study
An observational study of Knee Osteoarthritis and Pain, Postoperative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain, Postoperative, Prosthesis (Internal) Complications
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 6 May 2019to 30 Jun 2020
- 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: Adult Patients undergoing elective primary Total knee arthroplasty or unicompartimental knee arthroplasty due to knee joint osteoarthritis coming to elective surgery at Cliniques universitaires Saint-Luc, Brussels
Who may be able to join
- Undergoing elective primary Total knee arthroplasty or unicompartmental knee arthroplasty due to knee joint osteoarthritis
- Older than 18 years
- Willing and able to complete pre and postoperative surveys
Who cannot join
- History of drug abuse
- Previous knee arthroplasty
- Mental disorders
- Rheumatoid arthritis
- Chronic renal disease
- Chronic hematological diseases (sickle cell disease, haemochromatosis...)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Jérémy Daxhelet, MD, jeremy.daxhelet@uclouvain.be
Emmanuel Thienpont, MD, PhD
About this study
In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors.
Read the detailed description
In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain.
The purpose of our study is to determine the impact of this problem and to better understand its risk factors.
This is a poorly studied issue and the study could better detect, evaluate and treat painful patients after knee replacement surgery.
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Prosthesis (Internal) Complications, Nocturnal Frequency
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Nocturia
What is being measured
The primary outcome is the main question the study is designed to answer.
nocturnal pain
response to question (yes-no) "Does the pain in the operated knee wake you up at night or prevent you from sleeping?"
Measured: from day 1 of surgery until 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start6 May 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Thienpont, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998943
- Sponsor's protocol ID
- 2019/17AVR/182
- Acronym
- NOCTURN-PAIN
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study
- ClinicalTrials.gov ID
- NCT03998943
- Acronym / sponsor ID
- NOCTURN-PAIN / 2019/17AVR/182
- Conditions
- Knee Osteoarthritis, Pain, Postoperative, Prosthesis (Internal) Complications, Nocturnal Frequency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 26 Jun 2019 (actual)
- 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.
In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors.
Detailed description
In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain.
The purpose of our study is to determine the impact of this problem and to better understand its risk factors.
This is a poorly studied issue and the study could better detect, evaluate and treat painful patients after knee replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients undergoing elective primary Total knee arthroplasty or unicompartimental knee arthroplasty due to knee joint osteoarthritis coming to elective surgery at Cliniques universitaires Saint-Luc, Brussels
Key inclusion criteria (3 listed)
- Undergoing elective primary Total knee arthroplasty or unicompartmental knee arthroplasty due to knee joint osteoarthritis
- Older than 18 years
- Willing and able to complete pre and postoperative surveys
Key exclusion criteria (6 listed)
- History of drug abuse
- Previous knee arthroplasty
- Mental disorders
- Rheumatoid arthritis
- Chronic renal disease
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
nocturnal pain
Time frame: from day 1 of surgery until 1 year post surgery
response to question (yes-no) "Does the pain in the operated knee wake you up at night or prevent you from sleeping?"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Emmanuel Thienpont, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Pain, Postoperative, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Jul 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Thienpont, MD, PhD (+32276442516, emmanuel.thienpont@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nocturnal pain (time frame: from day 1 of surgery until 1 year post surgery). 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 12 Jul 2019.