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Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis

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ClinicalTrials.gov Identifier: NCT03200886
Recruitment Status : Unknown
Verified June 2017 by fioravanti antonella, Azienda Ospedaliera Universitaria Senese.
Recruitment status was:  Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
fioravanti antonella, Azienda Ospedaliera Universitaria Senese

Brief Summary:

Osteoarthritis of the trapeziometacarpal joint (TMJ), also called rhizarthrosis is a common disease, mostly affecting post-menopausal women. Intra-articular therapy with hyaluronic acid (HA) was usually recommended as a second-line treatment after failure of non-pharmacological modalities, only in early stages of the disease .Aim of the present observational, retrospective, comparative study is the assessment of the efficacy and tolerability of i.a. injections of an hybrid HA formulation (Synovial H-L®) in comparison to triamcinolone in patients with TMJ Osteoarthritis (OA). We are analyzing the records collected in the departmental archives of outpatients affected by TMJ OA, according to the ACR criteria for the classification for hand OA and who were treated with i.a. Sinovial H-L or triamcinolone acetonide from December 1st, 2015 to December 1st 2016.The patient's assessment of spontaneous hand pain on a 0-100 mm VAS with 0 representing the absence of pain and the FIHOA score validated in Italian language were routinely recorded and documented in our centre prior to the injections (T0), at the time of the second i.a. administration (T1), after one month (T2) and after 3 (T3) and 6 months (T4) following the i.a. therapy.

The primary outcome criteria of our study is the change of VAS and FIHOA from baseline to the end of treatment. Furthermore, we chose as secondary outcomes the duration of morning stiffness, the Italian version of Health Assessment Questionnaire (HAQ) and the validated Italian version of the Medical Outcomes Study 36-Item Short Form (SF-36) routinary registered in our medical record before the i.a. therapy, at the end of the treatment and after 1, 3 and 6 months.

The chi square test, t test or Kruskal-Wallis test, as appropriated, will be used to evaluate differences between groups before i.a. treatment the clinical and demographical data.

Mixed-effects linear regression models will be used to evaluate temporal trends and differences in the two groups for specific outcomes: VAS pain, VAS stiffness, FIHOA and PCS and MCS from SF-36 questionnaires. In these types of statistical models, the effects of the covariates and their standard errors are correctly estimated taking into account the hierarchical structure of the data (i.e., patients and visits). For the compute of SF-36s Z score will be used mean and SD of U.S. general population. Data analysis will be performed using Stata vers 13.0 software. Descriptive statistics will be used to summarize data as frequencies (categorical variables) or mean +/-SD (continuous variables) as appropriate. P values <0.05 is considered statistically significant.


Condition or disease Intervention/treatment
Osteoarthritis Thumb Device: Sinovial H-L Drug: Triamcinolone Acetonide

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : May 31, 2017
Estimated Study Completion Date : June 30, 2017


Group/Cohort Intervention/treatment
Sinovial H-L Group
The patients treated have received one cycle of two injections (at baseline and 15 days apart) of 1 ml of Sinovial H-L® (3.2% - 16mg + 16mg, Ibsa).
Device: Sinovial H-L
Patients were treated with an hybrid form of hyaluronic acid (Sinovial H-L) obtained through thermo-chemical processes from the combination of high (1100-1400 kDa) and low (80-100 kDa) MW fractions.

Control Group
The patients have received two i.a. injections (at baseline and 15 days apart) of 0.5 ml of triamcinolone acetonide (Kenacort® 20 mg, Bristol-Myers Squibb Srl).
Drug: Triamcinolone Acetonide
The patients have received two i.a. injections (at baseline and 15 days apart) of 0.5 ml of triamcinolone acetonide (Kenacort® 20 mg, Bristol-Myers Squibb Srl)




Primary Outcome Measures :
  1. Change of VAS [ Time Frame: basal time; 2 weeks; 1 month; 3 months; 6 months ]
    0-100 mm VAS with 0 representing the absence of pain.

  2. Change of FIHOA [ Time Frame: basal time; 2 weeks; 1 month; 3 months; 6 months ]
    FIHOA validated in Italian language


Secondary Outcome Measures :
  1. Change of duration of morning stiffness [ Time Frame: basal time; 2 weeks;1 month; 3 months; 6 months ]
    measured in minutes

  2. Change of Health Assessment Questionnaire (HAQ) [ Time Frame: basal time; 2 weeks; 1 month; 3 months; 6 months ]
    Italian version of HAQ

  3. Change of the Medical Outcomes Study 36-Item Short Form (SF-36) [ Time Frame: basal time; 2 weeks; 1 month; 3 months; 6 months ]
    validated Italian version of SF-36



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 patients of both sex affected by TMJ OA
Criteria

Inclusion Criteria:

  • clinical symptoms in the treated thumb for at least 3 months prior to the beginning of i.a. treatment with at least 30 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand OA (FIHOA) score of at least 6
  • radiographic evidence of TMJ OA within the previous 6 months with a radiological score of II-III (using the Kellgren method)

Exclusion Criteria:

  • any inflammatory joint disease
  • septic arthritis
  • major trauma
  • prior surgery of the hand, wrist, and elbow
  • coagulation disorders
  • severe comorbidity
  • past therapy with chondroitin sulfate, glucosamine, diacerein, steroids by any route of administration
  • i.a. injection of any joint with corticosteroids or HA during the previous 6 months

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): NCT03200886


Locations
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Italy
Azienda Ospedaliera Senese
Siena, Italy, 53100
Sponsors and Collaborators
University of Siena
Investigators
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Principal Investigator: Sara Tenti, MD University of Siena
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: fioravanti antonella, Antonella Fioravanti, MD, PhD, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier: NCT03200886    
Other Study ID Numbers: COMB-IAL-V-TRIAM 01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by fioravanti antonella, Azienda Ospedaliera Universitaria Senese:
hyaluronic acid
intra-articular injections
triamcinolone
osteoarthritis of the thumb
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action