- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417686
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: vincent VIDAL
- Email: vincent.vidal@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Email: drci@ap-hm.fr
-
Principal Investigator:
- vinent vidal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patient
|
arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
arterial embolization
Time Frame: 12 MONTHS
|
12 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS pain score
Time Frame: 12MONTHS
|
12MONTHS
|
Western Ontario and Universities Osteroarthritis Index (WOMAC) score
Time Frame: 12MONTHS
|
12MONTHS
|
SF36 quality of life score
Time Frame: 12 MONTHS
|
12 MONTHS
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-22
- 2019-A00746-51 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Inflammatory
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingInflammatory Myositis | Idiopathic Inflammatory Myositis | Drug-induced Inflammatory MyositisFrance
-
Groupe Hospitalier Pitie-SalpetriereRecruitingInflammatory Myositis | Idiopathic Inflammatory Myositis | Drug-induced Inflammatory MyositisFrance
-
Peking University People's HospitalUnknownInflammatory Myopathy
-
Peking University People's HospitalUnknown
-
University of ManchesterKing's College Hospital NHS Trust; Northern Care Alliance NHS Foundation Trust and other collaboratorsActive, not recruitingMyositis | Idiopathic Inflammatory MyopathyUnited Kingdom
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
-
Sunnybrook Health Sciences CentreCanadian Initiative for Outcomes in Rheumatology CareTerminated
-
University of LorraineUnknownInflammatory Arthritis
Clinical Trials on arterial embolization
-
Rigshospitalet, DenmarkCompleted
-
Peking University People's HospitalNot yet recruitingPelvic Tumor | Embolization
-
Odense University HospitalCompleted
-
Antonios LikourezosWithdrawnBenign Prostatic HyperplasiaUnited States
-
Fundación para la Investigación del Hospital Clínico...CompletedEsophageal Anastomotic Leak | Tissue Pressure of OxygenSpain
-
Next Biomedical Co., Ltd.RecruitingOsteoarthritisKorea, Republic of
-
Next Biomedical Co., Ltd.RecruitingOsteoarthritisKorea, Republic of
-
University of Alabama at BirminghamVarian, a Siemens Healthineers CompanyRecruitingRenal Cell Carcinoma (RCC)United States
-
Vascular Institute of VirginiaTerumo Medical CorporationUnknownAdhesive Capsulitis | Frozen ShoulderUnited States