Clinical trial NCT03431584: Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Official title: Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhizarthrosis
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis.

The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.

No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.


Eligibility criteria: Inclusion Criteria:

* Adults, ≥ 40 years
* Pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement
* Pain resistant to well-conducted medical treatment, with analgesics, NSAIDs, icing with pain (analog visual scale) ≥ 4 for more than 3 months
* Radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage II or III of Eaton and Litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint:

  * marginal osteophyte
  * pinching of the joint space
  * sclerosis of the subchondral space
  * subchondral kyst
  * absence of osteopenia
* Patient with the ability to understand the protocol and signed informed consent
* Patient receiving social security

Exclusion Criteria:

* Known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol)
* Change of analgesic treatment within 4 weeks before inclusion.
* Patients with symptomatic bilateral rhizarthrosis
* Scaphoid-trapezial arthrosis
* Local or general infection
* Severe coagulation disorders, ongoing anticoagulant therapy
* severe and / or uncontrolled hypertension
* Earlier local surgery
* Associated inflammatory rheumatism
* Tendinopathy of De Quervain, thumb to jump associated
* Infiltrations earlier than 6 months
* Diabetes imbalanced
* Live vaccines
* Severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure)
* Pregnant or lactating women
* Immunocompromised or hemodialysis patients
* Patients under guardianship, trusteeship, or deprived of liberty
* Patients participating in another clinical research protocol involving a drug or medical device
* Patients unable to follow the protocol, according to the judgment of the investigator

Primary outcomes:
measure: Analogical visual scale of pain (VAS)
timeFrame: 3 month post infiltration
Secondary outcomes:
measure: Progression of pain to activity at protocol follow-up visits
timeFrame: 1 month, 6 month, and 12 month post infiltration
measure: Progression of pain at rest at protocol follow-up visits
timeFrame: Base-line,1 month, 3month, 6 month, and 12 month post infiltration
measure: Comparison of pain between M0 and M3, by weekly collection on a patient book
timeFrame: 3 month post infiltration
measure: Evolution of the fhand unction with Cochin Hand Function Scale
timeFrame: 1 month, 6 month, and 12 month post infiltration
measure: Evolution of the grip and opposition force
timeFrame: 1 month, 3 month, 6 month, and 12 month post infiltration
measure: Ultrasound appearance of lesions
timeFrame: Baseline and 3 month post infiltration
measure: Comparison of infiltration pain
timeFrame: the day of infiltration
measure: Patient's feelings about the evolution of his pain
timeFrame: 3 month post infiltration
measure: Need for new infiltrations
timeFrame: over the 12 months of follow-up
measure: Use of analgesics and NSAIDs
timeFrame: over the 12 months of follow-up
measure: Need for surgical procedure
timeFrame: over the 12 months of follow-up
measure: Number of days off work
timeFrame: over the 12 months of follow-up
Other outcomes:
Locations:
city: Cholet
country: France
facility: CH Cholet
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: CH Le Mans
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References:
citation: Cormier G, Le Goff B, Denis A, Varin S, Auzanneau L, Dimet J, Le Thuaut A. Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. BMJ Open. 2019 Jan 9;9(1):e022553. doi: 10.1136/bmjopen-2018-022553.