NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study

Knee Osteoarthritis Clinical Trial

— NOCTURN-PAIN  

Official title:

NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03998943
• Other study ID #: 2019/17AVR/182
• Status: Recruiting
• Start date: May 6, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Emmanuel Thienpont, MD, PhD
• Phone: +32276442516
• Email: emmanuel.thienpont[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Nocturia
• Nocturnal Frequency
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative
• Prosthesis (Internal) Complications

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nocturnal pain	response to question (yes-no) "Does the pain in the operated knee wake you up at night or prevent you from sleeping?"	from day 1 of surgery until 1 year post surgery