Total Knee ArthroplastyKNEE BDNFNCT04604847
Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
A study testing blood test in people with Total Knee Arthroplasty and Chronic Postoperative Pain, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Chronic Postoperative Pain
- What is being tested?
- blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2020to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social security affiliation
- Adult patients
- Signed informed consent
- Score ASA (American Society of Anesthesiology) 1-3
- Total knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology and critical care, Lapeyronie University Hospital
Montpellier, 34295
About this study
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.
Read more
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.
- Being tested
- blood test
- Keywords
- Chronic Postoperative Pain, Brain Derived Neurotrophic Factor
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testDiagnostic test
blood test to explore BDNF level
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Other | patient operated for a total knee arthroplasty Receives: Diagnostic Test: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF level
assessed by ELISA technique
Measured: preoperative to 6 months after surgery
Secondary outcomes (8)
Pain level
evaluated by Visual Analog Scale (VAS)
Measured: preoperative to 6 months after surgery
Neuropathic pain diagnostic
evaluated by neuropathic pain diagnostic questionnaire (DN4)
Measured: preoperative to 6 months after surgery
Postoperative rehabilitation
evaluated by the Brief Pain Questionary (BPI)
Measured: preoperative to 6 months after surgery
Health related quality of life
evaluated by the SF-12 Health Survey
Measured: preoperative to 6 months after surgery
Anxiety and Depression
evaluated by the Hospital Anxiety and Depression scale (HAD)
Measured: preoperative to 6 months after surgery
Pain level perception
evaluated by the The pain Catastrophizing Scale
Measured: preoperative to 6 months after surgery
Assessment of functional capacities in knee arthritis
evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: preoperative to 6 months after surgery
Oxidative stress marker
8-iso-prostaglandin F2α level by biochemical labeling
Measured: preoperative to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start4 Dec 2020
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604847
- Sponsor's protocol ID
- RECHMPL19_0192
- Acronym
- KNEE BDNF
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics
- ClinicalTrials.gov ID
- NCT04604847
- Acronym / sponsor ID
- KNEE BDNF / RECHMPL19_0192
- Keywords
- Chronic Postoperative Pain, Brain Derived Neurotrophic Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | Other | Diagnostic Test: blood testpatient operated for a total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Social security affiliation
- Adult patients
- Signed informed consent
- Score ASA (American Society of Anesthesiology) 1-3
- Total knee arthroplasty
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood testblood test to explore BDNF level | Diagnostic test | Total knee arthroplasty |
Primary outcome
BDNF level
Time frame: preoperative to 6 months after surgery
assessed by ELISA technique
8 secondary outcomes
Pain level
Time frame: preoperative to 6 months after surgery
Neuropathic pain diagnostic
Time frame: preoperative to 6 months after surgery
Postoperative rehabilitation
Time frame: preoperative to 6 months after surgery
Health related quality of life
Time frame: preoperative to 6 months after surgery
Anxiety and Depression
Time frame: preoperative to 6 months after surgery
Pain level perception
Time frame: preoperative to 6 months after surgery
Assessment of functional capacities in knee arthritis
Time frame: preoperative to 6 months after surgery
Oxidative stress marker
Time frame: preoperative to 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood test in people with Total Knee Arthroplasty and Chronic Postoperative Pain, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF level (time frame: preoperative to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.