Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis

NCT03726788 | Withdrawn Phase 2 DMC

• 1 other identifier: RC-P0037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Joint Diseases; Knee; Therapeutics; Magnetic Resonance Imaging

Keywords

knee; Arthrosis; Botulinum toxin; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value

  one month post-injection

Secondary Outcomes (6)

• Pain analysis by the visual analogue scale (VAS)

  during the first 3 months after injection

• Joint amplitude measured by goniometry

  at 1, 3, 6 month post-injection

• Western Ontario McMaster University Osteoarthritis (WOMAC) Index

  at 1, 3, 6 month post-injection

• Two minutes walk

  at 1, 3, 6 month post-injection

• Frequency of consumption of analgesics

  at 1, 3, 6 month post-injection

Study Arms (3)

Botulinum Toxin Type A 100U

EXPERIMENTAL

one intra-articular injection in the painful knee 30 days after the inclusion visit

Drug: Botulinum Toxin Type A 100U

Botulinum Toxin Type A 200U

EXPERIMENTAL

one intra-articular injection in the painful knee 30 days after the inclusion visit

Drug: Botulinum Toxin Type A 200U

Triamcinolone Hexacetonide 20 MG/ML

ACTIVE COMPARATOR

one intra-articular injection in the painful knee 30 days after the inclusion visit

Drug: Triamcinolone Hexacetonide Inj Susp 20 MG/ML

Interventions

Botulinum Toxin Type A 100U DRUG

one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI

Also known as: Botox 100 UNT Injection

Botulinum Toxin Type A 100U

Botulinum Toxin Type A 200U DRUG

one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI

Also known as: Botox 200 UNT Injection

Botulinum Toxin Type A 200U

Triamcinolone Hexacetonide Inj Susp 20 MG/ML DRUG

one intra-articular injection of 2 ml Triamcinolone Hexacetonide

Also known as: HEXATRIONE

Triamcinolone Hexacetonide 20 MG/ML

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• Allergan: collaborator

Study Sites (1)

Lille Catholic University

Lille, 59000, France

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hichem Khenioui, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only pharmacists and radiologists know the patient's randomizing arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: September 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: April 1, 2022
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)