Not provided
Not provided
Not provided
Not provided
discontinuation of the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
Knee osteoarthritis is one of the most common causes of joint pain and functional disability in the general population.
Intra-articular infiltrations of corticoids are indicated for painful crisis especially if accompanied of effusion. However, this effect lasts only 2 weeks.
Given the lack of effective long-term medical-infiltrative treatment, we believe that botulinum toxin type A could be used by its direct action on mediators of neuro-gene inflammation at the joint level and its indirect medullary action by retrograde migration.
To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis.
Dynamic Contrast Enhancement (DCE) Magnetic Resonance Imaging (MRI) demonstrated the correlation between synovial inflammation and pain in gonarthrosis in a cohort of 454 subjects. It has also made it possible, via the monitoring of synovial inflammation, to demonstrate the efficacy of treatments in patients suffering from rheumatoid arthritis in the early phase, juvenile chronic arthritis or osteoarthritis.
DCE MRI perfusion therefore appears here as the technique of choice to follow the evolution of synovial inflammation after botulinum toxin injection in patients with symptomatic gonarthrosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Type A 100U | Experimental | one intra-articular injection in the painful knee 30 days after the inclusion visit |
|
| Botulinum Toxin Type A 200U | Experimental | one intra-articular injection in the painful knee 30 days after the inclusion visit |
|
| Triamcinolone Hexacetonide 20 MG/ML | Active Comparator | one intra-articular injection in the painful knee 30 days after the inclusion visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain analysis by the visual analogue scale (VAS) | Evolution kinetics of daily pain collected during the first 3 months post-injection allowing to deduce the onset and duration of analgesic efficacy in number of days. The pain VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "pain as bad as it could be" (score of 100 [100-mm scale]) |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hichem Khenioui, MD | GHICL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lille Catholic University | Lille | 59000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Only pharmacists and radiologists know the patient's randomizing arm.
| 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 |
|
|
| Triamcinolone Hexacetonide Inj Susp 20 MG/ML | Drug | one intra-articular injection of 2 ml Triamcinolone Hexacetonide |
|
|
| during the first 3 months after injection |
| Joint amplitude measured by goniometry | To measure range of motion of the knee | at 1, 3, 6 month post-injection |
| Western Ontario McMaster University Osteoarthritis (WOMAC) Index | An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability | at 1, 3, 6 month post-injection |
| Two minutes walk | This test measure the distance walked in two minutes | at 1, 3, 6 month post-injection |
| Frequency of consumption of analgesics | at 1, 3, 6 month post-injection |
| Amount of consumption of analgesics | at 1, 3, 6 month post-injection |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |