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出境医 / 临床实验 / NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study (NOCTURN-PAIN)
NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study (NOCTURN-PAIN)
Study Description
Brief 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.
| Condition or disease |
|---|
| Knee Osteoarthritis Pain, Postoperative Prosthesis (Internal) Complications Nocturnal Frequency |
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
| Study Type : | Observational |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study |
| Actual Study Start Date : | May 6, 2019 |
| Estimated Primary Completion Date : | June 30, 2020 |
| Estimated Study Completion Date : | June 30, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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?"
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of drug abuse
- Previous knee arthroplasty
- Mental disorders
- Rheumatoid arthritis
- Chronic renal disease
- Chronic hematological diseases (sickle cell disease, haemochromatosis...)
Contacts and Locations
Contacts
| Contact: Emmanuel Thienpont, MD, PhD | +32276442516 | emmanuel.thienpont@uclouvain.be | |
| Contact: Jérémy Daxhelet, MD | +32276442516 | jeremy.daxhelet@uclouvain.be |
Locations
| Belgium | |
| Cliniques universitaires Saint-Luc | Recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Jérémy Daxhelet, MD jeremy.daxhelet@uclouvain.be | |
| Principal Investigator: Emmanuel Thienpont, MD, PhD | |
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
| Principal Investigator: | Emmanuel Thienpont, MD, PhD | Cliniques universitaires Saint-Luc |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 25, 2019 | ||||||||
| First Posted Date | June 26, 2019 | ||||||||
| Last Update Posted Date | July 12, 2019 | ||||||||
| Actual Study Start Date | May 6, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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?"
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| Original Primary Outcome Measures |
nocturnal pain [ Time Frame: from day 1 of surgery until 1 year post surgery ] Does the pain in the operated knee wake you up at night or prevent you from sleeping
|
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study | ||||||||
| Official Title | NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study | ||||||||
| Brief 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. | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| 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 | ||||||||
| Condition |
|
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
250 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | June 30, 2020 | ||||||||
| Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Belgium | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03998943 | ||||||||
| Other Study ID Numbers | 2019/17AVR/182 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||||||
| Study Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||||||||
| Verification Date | July 2019 | ||||||||
