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

NCT03200886 | Unknown DMC FDA Drug

• 1 other identifier: COMB-IAL-V-TRIAM 01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Thumb

Keywords

hyaluronic acid; intra-articular injections; triamcinolone; osteoarthritis of the thumb

Outcome Measures

Primary Outcomes (2)

• Change of VAS

  0-100 mm VAS with 0 representing the absence of pain.

  basal time; 2 weeks; 1 month; 3 months; 6 months

• Change of FIHOA

  FIHOA validated in Italian language

  basal time; 2 weeks; 1 month; 3 months; 6 months

Secondary Outcomes (3)

• Change of duration of morning stiffness

  basal time; 2 weeks;1 month; 3 months; 6 months

• Change of Health Assessment Questionnaire (HAQ)

  basal time; 2 weeks; 1 month; 3 months; 6 months

• Change of the Medical Outcomes Study 36-Item Short Form (SF-36)

  basal time; 2 weeks; 1 month; 3 months; 6 months

Study Arms (2)

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

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

Interventions

Sinovial H-L DEVICE

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.

Sinovial H-L Group

Triamcinolone Acetonide DRUG

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)

Control Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 patients of both sex affected by TMJ OA

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Azienda Ospedaliera Senese

Siena, 53100, Italy

Location

Related Publications (5)

• Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.

  PMID: 17046965 RESULT

• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

  PMID: 22563589 RESULT

• Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, Chevalier X, Migliore A. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015 Oct;45(2):140-9. doi: 10.1016/j.semarthrit.2015.04.011. Epub 2015 Apr 30.

  PMID: 26094903 RESULT

• Fioravanti A, Cantarini L, Chellini F, Manca D, Paccagnini E, Marcolongo R, Collodel G. Effect of hyaluronic acid (MW 500-730 kDa) on proteoglycan and nitric oxide production in human osteoarthritic chondrocyte cultures exposed to hydrostatic pressure. Osteoarthritis Cartilage. 2005 Aug;13(8):688-96. doi: 10.1016/j.joca.2005.03.006.

  PMID: 15923130 RESULT

• Tenti S, Pascarelli NA, Giannotti S, Galeazzi M, Giordano N, Fioravanti A. Can hybrid hyaluronic acid represent a valid approach to treat rizoarthrosis? A retrospective comparative study. BMC Musculoskelet Disord. 2017 Nov 13;18(1):444. doi: 10.1186/s12891-017-1809-5.

  PMID: 29132341 DERIVED

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sara Tenti, MD

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Antonella Fioravanti, MD, PhD

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 27, 2017
• Study Start: May 24, 2017
• Primary Completion: May 31, 2017
• Study Completion: June 30, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

IT (1)