NCT03998943

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

June 25, 2019

Last Update Submit

July 10, 2019

Conditions

Knee OsteoarthritisPain, PostoperativeProsthesis (Internal) ComplicationsNocturnal Frequency

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • History of drug abuse
  • Previous knee arthroplasty
  • Mental disorders
  • Rheumatoid arthritis
  • Chronic renal disease
  • Chronic hematological diseases (sickle cell disease, haemochromatosis...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneePain, PostoperativeNocturia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsLower Urinary Tract SymptomsUrological Manifestations

Study Officials

  • Emmanuel Thienpont, MD, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Thienpont, MD, PhD

CONTACT

+32276442516emmanuel.thienpont@uclouvain.be

Jérémy Daxhelet, MD

CONTACT

+32276442516jeremy.daxhelet@uclouvain.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 26, 2019

Study Start

May 6, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)