Neovascularization Embolisation for Knee Osteoarthritis.(NEO)
Study Details
Study Description
Brief Summary
In this double blind randomized sham controlled study the investigators want to establish the efficacy of transcatheter arterial embolization of neovessels for patients with symptomatic mild to moderate knee osteoarthritis after 4 months compared to a sham-embolization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Rationale:
Transcatheter arterial embolization has recently been proposed as an efficacious therapy for therapy-resistant osteoarthritis of the knee, providing substantial pain reduction at short-term as well as long-term follow-up up till 4 years.
A potential working mechanism of treatment effect is that the normalization of the amount of blood vessels and blood flow achieved by embolization reduces inflammation, resulting in pain reduction
Objective:
The main objective is to assess whether transcatheter arterial embolization of neovessels in patients with symptomatic knee OA results in significant pain reduction after 4 months compared to sham treatment.
The investigators hypothesize that novel transcatheter arterial embolization of neovessels is a feasible, effective, and safe treatment for patients with symptomatic radiographic knee OA, resulting in significant improvement of pain symptoms in a period of 4 months follow-up compared to sham embolization.
Secondary objectives are
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to assess whether reduction of neovessels is related to pain relief,
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to explore whether decrease of inflammation is a mediating factor between neovessel reduction and pain relief,
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to assess whether transcatheter arterial embolization reduction of neovessels decreases peripheral and central pain sensitization and
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to assess whether transcatheter arterial embolization improve the outcome at 1, 4, 8 and 12 months compared to placebo of the: ICOAP, painDETECT, EQ-5D-5L questionnaires and NRS for pain.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Embolization group Group undergoes transcatheter arterial embolization of neovessels around the knee. |
Procedure: Embolization
transcatheter arterial embolization of neovessels around the knee
|
| Sham Comparator: Sham Embolization Group Group undergoes sham embolization |
Procedure: Sham embolization
Sham transcatheter arterial embolization of neovessels in the knee
|
Outcome Measures
Primary Outcome Measures
- KOOS pain sub score [4 months]
KOOS pain sub score after 4 months
Secondary Outcome Measures
- Total KOOS [1,4,8,12 month(s)]
Total KOOS result
- painDETECT questionnaire [1,4,8,12 month(s)]
painDETECT questionnaire results
- ICOAP questionnaire [1,4,8,12 month(s)]
ICOAP questionnaire results
- Pain Score 0-10 Numerical Rating Scale (NRS) [1,4,8,12 month(s)]
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
- EQ-5D-5L questionnaire [1,4,8,12 month(s)]
EQ-5D-5L questionnaire results
- Pressure pain threshold testing [1,4,8,12 month(s)]
Pressure pain threshold testing results
- Knee MRI [1 and 4 month(s)]
Knee MRI scan results
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age.≥18 years
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Knee pain for a duration of ≥ 6 months
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Knee pain (numeric rating scale ≥4 - ≤8) on at least half of the days in the preceding month at time of inclusion.
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There is insufficient response of conservative treatment for at least 6 months
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Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade 1-3)
Exlusion criteria:
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Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
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Contra-indications for angiography
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Renal insufficiency, checked with blood sample test (GFR < 30 ml/min/1, 73 m2);
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Known allergy to contrast agents;
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Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene
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Women who are pregnant or lactating
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Intermittent claudication of affected limb
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Intra articular injections in the ipsilateral knee less than 6 months ago
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On the waiting list for joint replacement surgery
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Amitriptyline usage.
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Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene.
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Insufficient command of the Dutch or English language.
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Legally incompetent adults.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ErasmusMC | Rotterdam | Zuid Holland | Netherlands | 3015CE |
Sponsors and Collaborators
- Erasmus Medical Center
- William Cook Europe
- Stichting Coolsingel
Investigators
- Principal Investigator: Edwin Edwin, MD, PhD, Erasmus Medical Center
- Principal Investigator: Adriaan Moelker, MD, PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- METC 2018-081
- 2018-081