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Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis. (RHIZ'ART)

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ClinicalTrials.gov Identifier: NCT03431584
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rhizarthrosis Drug: infiltration of corticosteroids Drug: infiltration of corticosteroids and hyaluronic acid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Infiltration of corticosteroids Drug: infiltration of corticosteroids
infiltration of corticosteroids
Experimental: Infiltration of corticosteroids and hyaluronic acid Drug: infiltration of corticosteroids and hyaluronic acid
infiltration of corticosteroids and hyaluronic acid


Outcome Measures
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Primary Outcome Measures :
  1. Analogical visual scale of pain (VAS) [ Time Frame: 3 month post infiltration ]
    Analogical visual scale of pain (VAS) To 0mm (no pain) form 100mm (maximum pain imaginable)


Secondary Outcome Measures :
  1. Progression of pain to activity at protocol follow-up visits [ Time Frame: 1 month, 6 month, and 12 month post infiltration ]
    Analogical visual scale of pain (VAS)

  2. Progression of pain at rest at protocol follow-up visits [ Time Frame: Base-line,1 month, 3month, 6 month, and 12 month post infiltration ]
    Analogical visual scale of pain (VAS)

  3. Comparison of pain between M0 and M3, by weekly collection on a patient book [ Time Frame: 3 month post infiltration ]
    Analogical visual scale of pain (VAS)

  4. Evolution of the fhand unction with Cochin Hand Function Scale [ Time Frame: 1 month, 6 month, and 12 month post infiltration ]
    Cochin Hand Function Scale

  5. Evolution of the grip and opposition force [ Time Frame: 1 month, 3 month, 6 month, and 12 month post infiltration ]
    dynamometer mesures

  6. Ultrasound appearance of lesions [ Time Frame: Baseline and 3 month post infiltration ]
    ultrasound b-mode and Doppler - gradation of OMERACT

  7. Comparison of infiltration pain [ Time Frame: the day of infiltration ]
    Analogical visual scale of pain (VAS)

  8. Patient's feelings about the evolution of his pain [ Time Frame: 3 month post infiltration ]
    Verbal Scale of global evolution

  9. Need for new infiltrations [ Time Frame: over the 12 months of follow-up ]
    Number of corticosteroid infiltrations

  10. Use of analgesics and NSAIDs [ Time Frame: over the 12 months of follow-up ]
    Use of analgesics and NSAIDs

  11. Need for surgical procedure [ Time Frame: over the 12 months of follow-up ]
    Number of patient requiring a surgical procedure

  12. Number of days off work [ Time Frame: over the 12 months of follow-up ]
    Number of days off work


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431584


Contacts
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Contact: Agnes Dorion 0251446380 ext +33 agnes.dorion@chd-vendee.fr

Locations
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France
CHD Vendée Recruiting
La Roche-sur-Yon, France, 85925
Principal Investigator: Grégoire CORMIER, PH         
CH Le Mans Not yet recruiting
Le Mans, France, 72037
Principal Investigator: Amélie DENIS, PH         
CHU Nantes Recruiting
Nantes, France, 44000
Principal Investigator: Benoit LE GOFF, PH         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT03431584    
Other Study ID Numbers: CHD 046-17
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents