Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lille Catholic University
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Presenting gonarthrosis of degenerative origin, Kellgren/Lawrence Radiological Stage I to III, with a maturity of more than 18 months

• With pain intensity greater than or equal to 50/100 on an VAS

• In case of bilateral gonarthrosis, the VAS of the contralateral knee must be less than or equal to 30/100

• Presenting a failure of conventional per os treatments (non-steroidal anti-inflammatory drugs, analgesics)

• Affiliated with a social security scheme

• For women of childbearing age:

• effective contraception for the duration of the study

Exclusion Criteria:

• Patient presenting at the time of the inclusion visit: an inflammatory attack, septic or inflammatory arthritis, a generalized infectious episode in progress

• Local or regional local skin lesion

• Need of an arthroplasty within the next 12 months

• Having received corticosteroids or other molecules in intra-articular infiltration in the last 6 months

• History of traumatic knee injury (bone injury in the past 24 months), bone, ligament or meniscal surgery in the past 24 months

• History of disabling peripheral nerve injury

• Severe bleeding disorders, anticoagulant treatment in progress or double antiplatelet aggregation

• BMI > 35 kg/m2

• Coxarthrosis with projected knee pain

• Pregnant or breastfeeding woman

• Patient under guardianship and protection of justice

• Allergy/contraindication to botulinum toxin type A, corticoids

• Usual contraindication to MRI

• Allergy to the contrast product