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ovel transcatheter arterial embolization for treatment of knee osteoarthritis: a randomized sham-controlled clinical trial

Recruiting
Conditions
degeneration of joint cartilage
10023213
10003216
Registration Number
NL-OMON50381
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
58
Inclusion Criteria

- Age * 18 years
- Knee pain for a duration of *6 months
- Knee pain (numeric rating scale *4 - *8) on at least half of the days in the
preceding month at
time of inclusion
- There is insufficient response of conservative treatment for at least 6 months
- Radiographic knee osteoarthritis (radiographic Kellgren and Lawrence grade
1-3)

Exclusion Criteria

- Contra-indications for MRI (e.g. metallic foreign bodies, etc.)
- Contra-indications for angiography
- Renal insufficiency, checked with blood sample test (GFR < 30 ml/min/1,73 m²);
- Known allergy to contrast agents;
- Patient has known allergies to barium sulfate, 3-aminopropyltrialkoxysilane,
polyphosphazene
- Women who are pregnant or lactating
- Intermittent claudication of affected limb
- Intra articular injections in the ipsilateral knee less than 6 months ago
- On the waiting list for joint replacement surgery
- Amitriptyline usage.
- Insufficient command of the Dutch or English language.
- Legally incompetent adults.
- Had previous surgical treatment for knee osteoarthritis (e.g. high tibial
osteotomy), excluding
knee arthroscopy
- Has musculoskeletal co morbidity (e.g. rheumatoid arthritis or gout)
potentially blurring the
effect of the treatment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Change of pain (measured with Knee injury and Osteoarthritis Outcome Score)<br /><br>between baseline and 4 months follow-up. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>NA</p><br>
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