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

June 26, 2017 updated by: fioravanti antonella, University of Siena

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Azienda Ospedaliera senese

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 patients of both sex affected by TMJ OA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of duration of morning stiffness
Time Frame: basal time; 2 weeks;1 month; 3 months; 6 months
measured in minutes
basal time; 2 weeks;1 month; 3 months; 6 months
Change of Health Assessment Questionnaire (HAQ)
Time Frame: basal time; 2 weeks; 1 month; 3 months; 6 months
Italian version of HAQ
basal time; 2 weeks; 1 month; 3 months; 6 months
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
basal time; 2 weeks; 1 month; 3 months; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Investigators

  • Principal Investigator: Sara Tenti, MD, University of Siena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

May 31, 2017

Study Completion (Anticipated)

June 30, 2017

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB-IAL-V-TRIAM 01

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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