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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-24

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Corticosteroid Intra-articular Injection in Hands Osteoarthritis

NCT02102620

Hands Osteoarthritis

COMPLETED PHASE4

Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis

NCT03211650

Knee Osteoarthritis

COMPLETED PHASE4

Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

NCT03431584

Rhizarthrosis

COMPLETED PHASE4

Randomized Placebo Controlled Study of Triamcinolone Acetonide Extended Release Injection for Thumb (CMC) Osteoarthritis

NCT06237153

Carpometacarpal (CMC) Osteoarthritis

RECRUITING PHASE2

NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

NCT05992883

Thumb Osteoarthritis

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis Thumb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Sinovial H-L

Intervention Type 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.

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).

Triamcinolone Acetonide

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No