Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03200886
Other study ID # COMB-IAL-V-TRIAM 01
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 14, 2017
Last updated June 26, 2017
Start date May 24, 2017
Est. completion date June 30, 2017

Study information

Verified date June 2017
Source University of Siena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date June 30, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Italy Azienda Ospedaliera Senese Siena

Sponsors (1)

Lead Sponsor Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Os — View Citation

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.se — View Citation

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 — View Citation

Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dinçer F, Dziedzic K, Häuselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martín-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Górska — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of VAS 0-100 mm VAS with 0 representing the absence of pain. basal time; 2 weeks; 1 month; 3 months; 6 months
Primary Change of FIHOA FIHOA validated in Italian language basal time; 2 weeks; 1 month; 3 months; 6 months
Secondary Change of duration of morning stiffness measured in minutes basal time; 2 weeks;1 month; 3 months; 6 months
Secondary Change of Health Assessment Questionnaire (HAQ) Italian version of HAQ basal time; 2 weeks; 1 month; 3 months; 6 months
Secondary Change of the Medical Outcomes Study 36-Item Short Form (SF-36) validated Italian version of SF-36 basal time; 2 weeks; 1 month; 3 months; 6 months
See also
  Status Clinical Trial Phase
Completed NCT04875156 - The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength N/A
Completed NCT03687775 - CMC I Stability Intraoperative
Recruiting NCT03196310 - Single Blinded First CMC Osteoarthritis Treatment N/A
Completed NCT05650970 - Radial Nerve Mobilization in Hand Thumb Osteoarthritis Patients N/A
Recruiting NCT06084364 - Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis Phase 4
Not yet recruiting NCT06370312 - Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints
Completed NCT03622736 - Influence of the Radiological Stage on the Efficiency of Viscosupplementation in Basal Thumb Arthritis
Completed NCT05275244 - Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2)
Recruiting NCT04458584 - Restoration of Thumb Strength and Function in Basal Joint Arthritis: A Comparative Effectiveness Trial (RESTART)
Completed NCT05849506 - Touch on One Thumb, RSI on the Other Thumb: Which Surgery Shows Better Results
Recruiting NCT06459063 - Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint Phase 1/Phase 2
Recruiting NCT06193499 - A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base. N/A
Recruiting NCT03815734 - Effects of Motor Imagery on Trapeziometacarpal Osteoarthritis in Women During the Postoperative Immobilization Period N/A
Active, not recruiting NCT04391751 - Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release N/A
Not yet recruiting NCT03327480 - The Effects of Two Different Orthosis on Pain, Hand Strength and Function in Patients With Thumb Carpometacarpal Osteoarthritis N/A
Recruiting NCT04676802 - Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone Phase 2
Recruiting NCT04217928 - Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis N/A
Recruiting NCT06151834 - Prospective Study of Arthrodesis of Finger Distal Interphalangeal Joints Using the Kerifuse Device N/A
Recruiting NCT05932628 - Thumb Osteoarthritis Prognosis for Supported Self-managment
Completed NCT06307847 - Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis Phase 3