NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Ri... | NCT03998943

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

NCT03998943

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Jul 12, 2019Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 6, 2019Actual

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Jun 25, 2019

First Submission Date that Met QC Criteria

Jun 25, 2019

First Posted Date

Jun 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2019

Last Update Posted Date

Jul 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emmanuel Thienpont, MD, PhD	Contact	+32276442516		emmanuel.thienpont@uclouvain.be
Jérémy Daxhelet, MD	Contact	+32276442516		jeremy.daxhelet@uclouvain.be

Overall Officials

Name	Affiliation	Role
Emmanuel Thienpont, MD, PhD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc	Recruiting	Brussels		1200	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010149	Pain, Postoperative
D053158	Nocturia

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided