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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04604847
Acronym
KNEE BDNF
Enrollment
200
Registered
2020-10-27
Start date
2020-12-04
Completion date
2024-03-19
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Postoperative Pain, Total Knee Arthroplasty

Keywords

Chronic Postoperative Pain, Brain Derived Neurotrophic Factor

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.

Interventions

DIAGNOSTIC_TESTblood test

blood test to explore BDNF level

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BDNF levelpreoperative to 6 months after surgeryassessed by ELISA technique

Secondary

MeasureTime frameDescription
Neuropathic pain diagnosticpreoperative to 6 months after surgeryevaluated by neuropathic pain diagnostic questionnaire (DN4)
Postoperative rehabilitationpreoperative to 6 months after surgeryevaluated by the Brief Pain Questionary (BPI)
Health related quality of lifepreoperative to 6 months after surgeryevaluated by the SF-12 Health Survey
Pain levelpreoperative to 6 months after surgeryevaluated by Visual Analog Scale (VAS)
Pain level perceptionpreoperative to 6 months after surgeryevaluated by the The pain Catastrophizing Scale
Assessment of functional capacities in knee arthritispreoperative to 6 months after surgeryevaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Oxidative stress markerpreoperative to 6 months after surgery8-iso-prostaglandin F2α level by biochemical labeling
Anxiety and Depressionpreoperative to 6 months after surgeryevaluated by the Hospital Anxiety and Depression scale (HAD)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026