Pilot Study of Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clinical assessment
Radiographic imaging
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres
Eligibility Criteria
Inclusion Criteria:
- Presence of knee pain
- Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
- Local tenderness around the knee
- Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid
- Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
- Patient is able to give consent
Exclusion Criteria:
- Previous knee surgery
- Local infection
- BMI > 40 kg/m2
- Advanced atherosclerosis
- Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
- Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed)
- Allergy to iodinated contrast medium or any other allergy
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Knee osteoarthritis
Arm Description
Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) for Knee Pain
To measure pain in patients with knee osteoarthritis
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
To evaluate symptoms and limitations in patients with knee osteoarthritis
MRI imaging
To depict potential asymptomatic, but radiologically visible side-effects
Secondary Outcome Measures
Full Information
NCT ID
NCT05013970
First Posted
August 12, 2021
Last Updated
August 17, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05013970
Brief Title
Pilot Study of Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Official Title
Pilot Study of Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
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
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Detailed Description
Disabling symptoms of osteoarthritis are seen in approximatively 10% of people over 55 years old. Traditionally, treatment of symptomatic knee osteoarthritis is based on administration of pain relievers, including nonsteroidal anti-inflammatory drugs, in case of mild to moderate symptoms; major joint replacement surgery (total joint arthroplasty) is performed in cases of severe and end-stage osteoarthritis.
However, many patients suffer from persistent pain symptoms from moderate osteoarthritis despite optimal medical treatment. For these patients, several minimally-invasive surgical treatments have been proposed, including arthroscopic lavage and debridement; however, none of these treatments have been proven effective compared to sham treatment.
Recently, catheter-directed embolotherapy of the geniculate arteries has been propagated as a real alternative to medical management in patients with mild to moderate knee osteoarthritis unresponsive to conservative medical management.
Transcatheter embolotherapy was performed using imipenem/cilastin sodium or 75 micron calibrated Embozene microspheres and follow-up was performed by physical examination, questionnaires (VAS-score and WOMAC-scores) and MR-imaging (WORMS-score). Results of these trials confirmed that catheter-directed embolotherapy is a safe procedure without any major adverse events. WOMAC pain scores dropped dramatically from 12.2 +/- 1.9 before the procedure to 3.3 +/- 2.1 at 1 month after the procedure and to 1.7 +/- 2.2 at 4 months after the procedure. Additionally, MR imaging at 2 years of follow-up could not demonstrate any osteonecrosis or progression of degenerative changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, Catheter-directed embolotherapy, Poly-vinyl alcohol microspheres
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with mild to moderate knee osteoarthritis
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee osteoarthritis
Arm Type
Other
Arm Description
Patients with mild to moderate osteoarthritis who suffer from persistent knee pain treated with catheter-directed geniculate artery embolization
Intervention Type
Other
Intervention Name(s)
Clinical assessment
Intervention Description
Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Intervention Type
Other
Intervention Name(s)
Radiographic imaging
Intervention Description
MRI of the knee
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for Knee Pain
Description
To measure pain in patients with knee osteoarthritis
Time Frame
Within 30 days after catheter-directed embolization
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Description
To evaluate symptoms and limitations in patients with knee osteoarthritis
Time Frame
Within 30 days after catheter-directed embolization
Title
MRI imaging
Description
To depict potential asymptomatic, but radiologically visible side-effects
Time Frame
At day 30 after catheter-directed embolization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of knee pain
Kellgren-Lawrence (KL) grade 1-3 assessed by weight-bearing knee radiographs
Local tenderness around the knee
Clinical failure after 3 months or more of conservative therapies, including oral nonsteroidal anti-inflammatory drugs and/or oral opioid agents and physical therapy, stretching, muscle strengthening and/or intra-articular injection of hyaluronic acid
Persistent moderate to severe knee pain (VAS > 50 mm) for more than 3 months
Patient is able to give consent
Exclusion Criteria:
Previous knee surgery
Local infection
BMI > 40 kg/m2
Advanced atherosclerosis
Rheumatoid arthritis, malignancy, renal insufficiency, other conditions contra-indicating femoropopliteal angiography
Usage of anticoagulants such as eliquis or coumarine (Asaflow allowed)
Allergy to iodinated contrast medium or any other allergy
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pilot Study of Transcatheter Arterial Embolization as a Treatment for Knee Pain in Patients With Mild to Moderate Osteoarthritis
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