Back to resultsARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
Primary Purpose
Musculoskeletal Inflammatory
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
arterial embolization
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Inflammatory
Eligibility Criteria
Inclusion Criteria:
- Adult patient (male or female) aged 18-85
- Suffering from moderate to severe chronic pain (EVA > 50mm) more than 6 months after total prosthetic knee replacement surgery for severe gonarthrosis with impact on quality of life.
- And having followed for at least 3 months a well-conducted conservative medical treatment (anti-inflammatory, analgesic, masso-kinesiotherapy).
- The patient may initially have had a single or bilateral replacement. The period of 6 months must be respected for each side, between the intervention and the inclusion for homolateral pain.
- Patient willing to participate in the study and with signed informed consent.
- Patient willing to undergo post-operative monitoring for one year.
Exclusion Criteria:
Orthopaedic or rheumatological pathologies:
- Rheumatoid arthritis
- Psoriatic rheumatism
- Spondylarthropathies
- History of primary or secondary bone tumor, in remission or active.
- Myeloma
- Operational criteria:
- Infection of the surgical site
- Re-operation
- Severe bleeding
- Use of turnstile per-operative
- Wound of popliteal artery
- Diabetic patient
- Comorbidities:
- General condition responsible for objective hemostasis disorder (hemophilia, Willebrand disease, thrombocytopenia) and anticoagulant treatments.
- Pads 100 G/L
Sites / Locations
- Assistance Publique Hopitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient
Arm Description
Outcomes
Primary Outcome Measures
arterial embolization
Secondary Outcome Measures
VAS pain score
Western Ontario and Universities Osteroarthritis Index (WOMAC) score
SF36 quality of life score
Full Information
NCT ID
NCT04417686
First Posted
June 2, 2020
Last Updated
August 5, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT04417686
Brief Title
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
Official Title
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.
Detailed Description
Hypothesis: Selective arterial embolization of persistent geniculate arteries could reduce chronic post-operative gonalgia after TKA with minimally invasive approach.
Objective: To evaluate the feasibility of selective arterial embolization of persistent geniculate arteries to reduce chronic post-operative gonalgia after TKA.
Material and methods: This study is a single-center, prospective, feasibility study. Patients will be recruited after rheumatology consultation for chronic post-operative gonalgia, more than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) > 50mm) and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade femoral access, patient will undergo selective arterial embolization of persistent and aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05 and power of 80% we require a cohort of 24 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
arterial embolization
Intervention Description
arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis
Primary Outcome Measure Information:
Title
arterial embolization
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
VAS pain score
Time Frame
12MONTHS
Title
Western Ontario and Universities Osteroarthritis Index (WOMAC) score
Time Frame
12MONTHS
Title
SF36 quality of life score
Time Frame
12 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (male or female) aged 18-85
Suffering from moderate to severe chronic pain (EVA > 50mm) more than 6 months after total prosthetic knee replacement surgery for severe gonarthrosis with impact on quality of life.
And having followed for at least 3 months a well-conducted conservative medical treatment (anti-inflammatory, analgesic, masso-kinesiotherapy).
The patient may initially have had a single or bilateral replacement. The period of 6 months must be respected for each side, between the intervention and the inclusion for homolateral pain.
Patient willing to participate in the study and with signed informed consent.
Patient willing to undergo post-operative monitoring for one year.
Exclusion Criteria:
Orthopaedic or rheumatological pathologies:
Rheumatoid arthritis
Psoriatic rheumatism
Spondylarthropathies
History of primary or secondary bone tumor, in remission or active.
Myeloma
Operational criteria:
Infection of the surgical site
Re-operation
Severe bleeding
Use of turnstile per-operative
Wound of popliteal artery
Diabetic patient
Comorbidities:
General condition responsible for objective hemostasis disorder (hemophilia, Willebrand disease, thrombocytopenia) and anticoagulant treatments.
Pads 100 G/L
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
vincent VIDAL
Email
vincent.vidal@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EMILIE GARRIDO PRADALIE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
vinent vidal
12. IPD Sharing Statement
Learn more about this trial
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
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