Back to resultsRFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA (RADIOPHENOL)
Primary Purpose
Osteo Arthritis Knee, Knee Pain Chronic
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Diagnostic genicular nerve block
Genicular nerve block with Radiofrequency Ablation (RFA)
Genicular nerve block with Phenol 6%
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Pain, Thermal ablation, Phenol neurolysis, Genicular nerve
Eligibility Criteria
Inclusion Criteria: Adult patients of both sexes, >35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons. OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function). Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration. Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI. Exclusion Criteria: Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware). Patient with a history of neurovascular injury or recent trauma of the lower extremities. Patient with chronic widespread pain. Polyneuropathy and/or radicular pain in the lower extremities. Patient is currently implanted with a neurostimulator. Local or systemic infection (bacteraemia). Uncontrolled immune suppression. Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation. Arthroscopic debridement/lavage into the target knee within 180 days from randomisation. BMI<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns). Allergies to products used during the procedure (lidocaine, phenol, contrast dye). Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure. Patients with psychosocial problems as determined by the investigator.
Sites / Locations
- Dijklander Ziekenhuis
- Bravis Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Chemical ablation of the genicular nerves with Phenol 6%
Radiofrequency ablation (RFA) of the genicular nerves
Conservative treatment
Arm Description
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.
Outcomes
Primary Outcome Measures
Knee function measured with the Oxford Knee score (OKS)
Questionnaire with 12 items. Scores can range from 0 to 48, with 48 being the best outcome and a lower score indicates more functional limitations and pain.
Secondary Outcome Measures
Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
We will use the WOMAC in the Likert version where question are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. So the sum of the scores ranges from 0 (the best) to 96 (the worse).
Pain measured with the Numeric Rating Score (NRS)
NRS will be measured in rest and during the performance based tests.
30 seconds chair-stand test
During this test the total number of complete chair stands (up and down represents one stand) is counted. If at least a full stand is completed at 30 seconds this is counted in the total. If a person cannot stand even once then the score for the test is zero.
40 meters (4x10m) fast-paced walk test
The total time taken to walk the 4 × 10 m, excluding turns, of one trial is recorded and expressed as speed m/s by dividing distance (40 m) by time (seconds). Timing is paused during turns.
9-steps stair-climb test
Total time to ascend and descend steps for one trial is recorded in seconds.
Health related quality of life with the EQ-5D-5L
The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. EQ-5D comprises a short questionnaire that is cognitively undemanding, taking only a few minutes to complete.
Hospital Anxiety and Depression Scale (HADS)
The Dutch version of the HADS is a fourteen-item scale with seven items for anxiety (HADS-A) and seven items for depression (HADS-D) (49). Scoring for each item ranges from zero to three. A higher score indicates more anxiety or depression.
Pain Catastrophizing Score (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire considered to be the most frequent and extensively studied tool to assess pain catastrophizing for chronic pain. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52. Higher scores indicate a higher level of catastrophizing.
Diagnostic block most appropriate cut-off value
The continuous results of the diagnostic nerve block in our study (percentage of pain relief) will be used to determine the best cut-off value for the positive outcome of the ablation. The cut-off value will be analysed with a receiver operating curve (ROC) analysis. Results equal or above this cut-off value are considered to predict a positive outcome of the ablation of the nerves, results below the cut-off value are considered to predict a negative outcome of the ablation of the nerve. For this analysis, a positive outcome of the ablation is defined as a MCID in OKS of 4.9 points at 3 months follow up.
Patient satisfaction
The patient satisfaction with the result of treatment will be measured with a 5-point Likert scale (1-5). The patients will be asked to grade the statement 'I am satisfied with the result of the treatment' with the following options:
Strongly disagree
Disagree
Neutral
Agree
Strongly agree
Patient Global Impression of Change (PGIC)
The PGIC in pain and function will be measured with a 5-point Likert scale (1-5) on the applicable follow up visits. The patients will be asked to rate the following statements:
Please imagine how you would have described your pain intensity before the procedure. How do you feel today as compared to baseline (Start of the study) as far as your knee pain caused by OA is concerned?
Please imagine how you would have described the functionality of your knee before the procedure. How do you feel today as compared to baseline (start of the study) as far as your knee functionality caused by OA is concerned?
The options on the Likert scale are:
much better
slightly better
no change
slightly worse
much worse
Minimal Clinically Important Difference (MCID) of the OKS
We will use distribution and anchor based methods to determine the MCID on the patient reported outcomes of the OKS.
Minimal Clinically Important Difference (MCID) of the WOMAC
We will use distribution and anchor based methods to determine the MCID on the patient reported outcomes of the WOMAC.
Minimal Clinically Important Difference (MCID) for the EQ-5D-5L
To determine the MCID on the patient reported outcomes of the EQ-5D-5L we will use an instrument defined method.
Minimal Clinically Important Difference (MCID) of the 30 seconds chair-stand test
We will use distribution and anchor based methods to determine the MCID of the 30 seconds chair-stand test.
Minimal Clinically Important Difference (MCID) of the 40 meters (4x10m) fast-paced walk test
We will use distribution and anchor based methods to determine the MCID of the 40 meters (4x10m) fast-paced walk test.
Minimal Clinically Important Difference (MCID) of the 9-steps stair-climb test.
We will use distribution and anchor based methods to determine the MCID of the 9-steps stair-climb test.
Adverse events
The reported treatment related or probably treatment related adverse events will be listed as numbers with frequencies per treatment.
Medication changes
The patients will be asked to report changes in the use of NSAIDs and opioids during the follow up visits. The results will be summarised as increased use, no change, decrease in use and use of opioids will be reported as MME.
Number of Total Knee Artroplasty's (TKA's)
The number of TKAs during the study follow up will be documented including the point in time since the intervention. If applicable, we will use the Kaplan-Meier estimator to estimate the survival function.
Procedure time
The total procedure time of chemical ablation and RFA will be measured in minutes. The measurement starts as soon as the treating physician puts on his sterile gloves and will end when the sterile draping is taken off.
Full Information
NCT ID
NCT06094660
First Posted
September 12, 2023
Last Updated
October 20, 2023
Sponsor
Dijklander Ziekenhuis
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bravis Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06094660
Brief Title
RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
Acronym
RADIOPHENOL
Official Title
Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dijklander Ziekenhuis
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bravis Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
Detailed Description
In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases the golden standard is joint replacing surgery. A less invasive technique is ablation of the sensory (genicular) nerves of the knee. This technique is beneficial for younger patients as a bridge to surgery or patients that cannot undergo total knee arthroplasty (TKA) due to comorbid health conditions. Nerve ablation can either be done with chemical agents or thermal energy.
Although there are numerous studies on genicular nerve block for chronic knee pain caused by OA, there are just a few small studies that compare genicular nerve block with conservative treatment.To be able to determine if genicular nerve ablation is efficacious to serve the gap between conservative treatment and TKA, this randomised controlled trial (RCT) compares two forms of genicular nerve ablation (radiofrequency and phenolisation; intervention) with conservative treatment (control) up to 6 months after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Knee Pain Chronic
Keywords
Pain, Thermal ablation, Phenol neurolysis, Genicular nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemical ablation of the genicular nerves with Phenol 6%
Arm Type
Active Comparator
Arm Description
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
Arm Title
Radiofrequency ablation (RFA) of the genicular nerves
Arm Type
Active Comparator
Arm Description
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
Arm Title
Conservative treatment
Arm Type
No Intervention
Arm Description
Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic genicular nerve block
Intervention Description
Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve block with Radiofrequency Ablation (RFA)
Intervention Description
Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve block with Phenol 6%
Intervention Description
Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.
Primary Outcome Measure Information:
Title
Knee function measured with the Oxford Knee score (OKS)
Description
Questionnaire with 12 items. Scores can range from 0 to 48, with 48 being the best outcome and a lower score indicates more functional limitations and pain.
Time Frame
During intake, before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Secondary Outcome Measure Information:
Title
Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
We will use the WOMAC in the Likert version where question are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. So the sum of the scores ranges from 0 (the best) to 96 (the worse).
Time Frame
Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Title
Pain measured with the Numeric Rating Score (NRS)
Description
NRS will be measured in rest and during the performance based tests.
Time Frame
In rest during intake and in rest and during performance based tests before and after the diagnostic nerve block (if applicable), before the intervention (if applicable), 6 weeks, 3 months, 6 months and 1 year after the intervention
Title
30 seconds chair-stand test
Description
During this test the total number of complete chair stands (up and down represents one stand) is counted. If at least a full stand is completed at 30 seconds this is counted in the total. If a person cannot stand even once then the score for the test is zero.
Time Frame
Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.
Title
40 meters (4x10m) fast-paced walk test
Description
The total time taken to walk the 4 × 10 m, excluding turns, of one trial is recorded and expressed as speed m/s by dividing distance (40 m) by time (seconds). Timing is paused during turns.
Time Frame
Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.
Title
9-steps stair-climb test
Description
Total time to ascend and descend steps for one trial is recorded in seconds.
Time Frame
Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.
Title
Health related quality of life with the EQ-5D-5L
Description
The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. EQ-5D comprises a short questionnaire that is cognitively undemanding, taking only a few minutes to complete.
Time Frame
Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The Dutch version of the HADS is a fourteen-item scale with seven items for anxiety (HADS-A) and seven items for depression (HADS-D) (49). Scoring for each item ranges from zero to three. A higher score indicates more anxiety or depression.
Time Frame
At T=0 (before intervention) and during T=3 (6 months after intervention)
Title
Pain Catastrophizing Score (PCS)
Description
The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire considered to be the most frequent and extensively studied tool to assess pain catastrophizing for chronic pain. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52. Higher scores indicate a higher level of catastrophizing.
Time Frame
At T=0 (before intervention) and during T=3 (6 months after intervention)
Title
Diagnostic block most appropriate cut-off value
Description
The continuous results of the diagnostic nerve block in our study (percentage of pain relief) will be used to determine the best cut-off value for the positive outcome of the ablation. The cut-off value will be analysed with a receiver operating curve (ROC) analysis. Results equal or above this cut-off value are considered to predict a positive outcome of the ablation of the nerves, results below the cut-off value are considered to predict a negative outcome of the ablation of the nerve. For this analysis, a positive outcome of the ablation is defined as a MCID in OKS of 4.9 points at 3 months follow up.
Time Frame
Before and after the diagnostic block and during T=2 (3 months after intervention).
Title
Patient satisfaction
Description
The patient satisfaction with the result of treatment will be measured with a 5-point Likert scale (1-5). The patients will be asked to grade the statement 'I am satisfied with the result of the treatment' with the following options:
Strongly disagree
Disagree
Neutral
Agree
Strongly agree
Time Frame
During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Title
Patient Global Impression of Change (PGIC)
Description
The PGIC in pain and function will be measured with a 5-point Likert scale (1-5) on the applicable follow up visits. The patients will be asked to rate the following statements:
Please imagine how you would have described your pain intensity before the procedure. How do you feel today as compared to baseline (Start of the study) as far as your knee pain caused by OA is concerned?
Please imagine how you would have described the functionality of your knee before the procedure. How do you feel today as compared to baseline (start of the study) as far as your knee functionality caused by OA is concerned?
The options on the Likert scale are:
much better
slightly better
no change
slightly worse
much worse
Time Frame
During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Title
Minimal Clinically Important Difference (MCID) of the OKS
Description
We will use distribution and anchor based methods to determine the MCID on the patient reported outcomes of the OKS.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up. .
Title
Minimal Clinically Important Difference (MCID) of the WOMAC
Description
We will use distribution and anchor based methods to determine the MCID on the patient reported outcomes of the WOMAC.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
Title
Minimal Clinically Important Difference (MCID) for the EQ-5D-5L
Description
To determine the MCID on the patient reported outcomes of the EQ-5D-5L we will use an instrument defined method.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
Title
Minimal Clinically Important Difference (MCID) of the 30 seconds chair-stand test
Description
We will use distribution and anchor based methods to determine the MCID of the 30 seconds chair-stand test.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
Title
Minimal Clinically Important Difference (MCID) of the 40 meters (4x10m) fast-paced walk test
Description
We will use distribution and anchor based methods to determine the MCID of the 40 meters (4x10m) fast-paced walk test.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
Title
Minimal Clinically Important Difference (MCID) of the 9-steps stair-climb test.
Description
We will use distribution and anchor based methods to determine the MCID of the 9-steps stair-climb test.
Time Frame
MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.
Title
Adverse events
Description
The reported treatment related or probably treatment related adverse events will be listed as numbers with frequencies per treatment.
Time Frame
After the diagnostic block, after the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.
Title
Medication changes
Description
The patients will be asked to report changes in the use of NSAIDs and opioids during the follow up visits. The results will be summarised as increased use, no change, decrease in use and use of opioids will be reported as MME.
Time Frame
Before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.
Title
Number of Total Knee Artroplasty's (TKA's)
Description
The number of TKAs during the study follow up will be documented including the point in time since the intervention. If applicable, we will use the Kaplan-Meier estimator to estimate the survival function.
Time Frame
At 6 weeks, 3 months, 6 months and 12 months follow up.
Title
Procedure time
Description
The total procedure time of chemical ablation and RFA will be measured in minutes. The measurement starts as soon as the treating physician puts on his sterile gloves and will end when the sterile draping is taken off.
Time Frame
During the intervention visit (T=0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of both sexes, >35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration.
Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
Exclusion Criteria:
Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
Patient with a history of neurovascular injury or recent trauma of the lower extremities.
Patient with chronic widespread pain.
Polyneuropathy and/or radicular pain in the lower extremities.
Patient is currently implanted with a neurostimulator.
Local or systemic infection (bacteraemia).
Uncontrolled immune suppression.
Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation.
Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
BMI<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns).
Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
Patients with psychosocial problems as determined by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gezina Oei, MD,PhD
Phone
0031229257257
Email
g.t.m.l.oei@dijklander.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Aine Honohan, MSc
Phone
0031646340596
Email
a.g.honohan@Dijklander.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gezina Oei, MD, PhD
Organizational Affiliation
Academic Medical Centre Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Hollmann, Prof
Organizational Affiliation
Academic Medical Centre Amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
Dijklander Ziekenhuis
City
Hoorn
State/Province
Noord-Holland
ZIP/Postal Code
1624NP
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gezina Oei, MD, PhD
Email
g.t.m.l.oei@dijklander.nl
First Name & Middle Initial & Last Name & Degree
Paul de Wit, MD
Email
p.r.dewit@dijklander.nl
Facility Name
Bravis Ziekenhuis
City
Roosendaal
ZIP/Postal Code
4708AE
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Elzinga
Email
l.elzinga@bravis.nl
First Name & Middle Initial & Last Name & Degree
Jeroen van der Heiden
Email
j.vdheiden@bravis.nl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol and the final data will be published. Conditions for reuse apply: A de-identified dataset will be made available upon request to the corresponding author. The request must include ethics approval and a statistical analysis plan.
An embargo period applies: The embargo period is at least 1 year after the publication of the original study.
IPD Sharing Time Frame
An embargo period applies: The embargo period is at least 1 year after the publication of the original study.
IPD Sharing Access Criteria
A de-identified dataset will be made available upon request to the corresponding author. The request must include ethics approval and a statistical analysis plan. Digital data and documentation will be preserved for 15 years.
Learn more about this trial
RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA
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