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Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics (KNEE BDNF)

Primary Purpose

Total Knee Arthroplasty, Chronic Postoperative Pain

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood test
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Total Knee Arthroplasty focused on measuring Chronic Postoperative Pain, Brain Derived Neurotrophic Factor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Social security affiliation
  • Adult patients
  • Signed informed consent
  • Score ASA (American Society of Anesthesiology) 1-3
  • Total knee arthroplasty

Exclusion Criteria:

  • Patient unable to exercise consent
  • Pregnant women
  • Vulnerable people
  • Patients not included in the postoperative rehabilitation program
  • Patients unable to complete the pain assessment questionnaires
  • Chronic pain patients (other than knee arthrosis)
  • Neuropathic pain patients (beforehand)
  • Inflammatory diseases, progressive cancer, sepsis, immunosuppression known

Sites / Locations

  • Department of Anesthesiology and critical care, Lapeyronie University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Total knee arthroplasty

Arm Description

patient operated for a total knee arthroplasty

Outcomes

Primary Outcome Measures

BDNF level
assessed by ELISA technique

Secondary Outcome Measures

Pain level
evaluated by Visual Analog Scale (VAS)
Neuropathic pain diagnostic
evaluated by neuropathic pain diagnostic questionnaire (DN4)
Postoperative rehabilitation
evaluated by the Brief Pain Questionary (BPI)
Health related quality of life
evaluated by the SF-12 Health Survey
Anxiety and Depression
evaluated by the Hospital Anxiety and Depression scale (HAD)
Pain level perception
evaluated by the The pain Catastrophizing Scale
Assessment of functional capacities in knee arthritis
evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Oxidative stress marker
8-iso-prostaglandin F2α level by biochemical labeling

Full Information

First Posted
October 12, 2020
Last Updated
June 8, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04604847
Brief Title
Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Acronym
KNEE BDNF
Official Title
Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
December 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic pain is an extremely disabling disease. It is a major public health problem due to the lack of effective therapy. Chronic postoperative pain (CPOP) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication. The prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty. Identification of clinical, biological and psychological profiles are crucial to prevent CPOP. A biologic factor, Brain Derived Neurotrophic Factor (BDNF) produced by a variety of cells is a key regulator of neuroplasticity. BDNF is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. The role of BDNF in pain of patients remains to be explored in a prospective study. The aim of this observational study is to compare the kinetics of BDNF after total knee arthroplasty in patients with and without CPOP. Patients will be included in the study at the preanesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Chronic Postoperative Pain
Keywords
Chronic Postoperative Pain, Brain Derived Neurotrophic Factor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study to analyze perioperative blood samples in patient after knee replacement surgery. Patients will be included in the study at the pre-anesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total knee arthroplasty
Arm Type
Other
Arm Description
patient operated for a total knee arthroplasty
Intervention Type
Diagnostic Test
Intervention Name(s)
blood test
Intervention Description
blood test to explore BDNF level
Primary Outcome Measure Information:
Title
BDNF level
Description
assessed by ELISA technique
Time Frame
preoperative to 6 months after surgery
Secondary Outcome Measure Information:
Title
Pain level
Description
evaluated by Visual Analog Scale (VAS)
Time Frame
preoperative to 6 months after surgery
Title
Neuropathic pain diagnostic
Description
evaluated by neuropathic pain diagnostic questionnaire (DN4)
Time Frame
preoperative to 6 months after surgery
Title
Postoperative rehabilitation
Description
evaluated by the Brief Pain Questionary (BPI)
Time Frame
preoperative to 6 months after surgery
Title
Health related quality of life
Description
evaluated by the SF-12 Health Survey
Time Frame
preoperative to 6 months after surgery
Title
Anxiety and Depression
Description
evaluated by the Hospital Anxiety and Depression scale (HAD)
Time Frame
preoperative to 6 months after surgery
Title
Pain level perception
Description
evaluated by the The pain Catastrophizing Scale
Time Frame
preoperative to 6 months after surgery
Title
Assessment of functional capacities in knee arthritis
Description
evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame
preoperative to 6 months after surgery
Title
Oxidative stress marker
Description
8-iso-prostaglandin F2α level by biochemical labeling
Time Frame
preoperative to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Social security affiliation Adult patients Signed informed consent Score ASA (American Society of Anesthesiology) 1-3 Total knee arthroplasty Exclusion Criteria: Patient unable to exercise consent Pregnant women Vulnerable people Patients not included in the postoperative rehabilitation program Patients unable to complete the pain assessment questionnaires Chronic pain patients (other than knee arthrosis) Neuropathic pain patients (beforehand) Inflammatory diseases, progressive cancer, sepsis, immunosuppression known
Facility Information:
Facility Name
Department of Anesthesiology and critical care, Lapeyronie University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics

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