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

NCT03200886 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Osteoarthritis Thumb

Interventions

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.

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)

Sponsors & Collaborators

  • University of Siena

    lead OTHER

Principal Investigators

  • Sara Tenti, MD · University of Siena

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2017-05-31
Completion
2017-06-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200886 on ClinicalTrials.gov