Comparison of Two Application Regimens for Viscosupplementation

NCT ID: NCT01824485

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-04-30

Brief Summary

Viscosupplementation by intra-articular injection of hyaluronate products has recently gained popularity as a treatment modality of gonarthritis.There is not, however, a consensus on the best method.Our objective is to evaluate what is the best dosage of viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide. One hundred and four patients with knee osteoarthritis (KOA) were divides into 2 groups of 52 patients each to receive either a single application of 3 ampoules of OSTEONIL® + 1ml of Hexacetonide of triamcinolone or three applications of 1 ampoule of OSTEONIL®, one per week for three weeks + 1ml of Hexacetonide of triamcinolone only in the first injection. Primary endpoint was clinical results expressed by Visual Analogic Scale of pain (VAS), Western Ontario and Mcmaster Universities (WOMAC) and Lequesne questionaires at one, three, six and 12 months after the procedure

Detailed Description

Viscosupplementation by intra-articular injection of hyaluronate products has recently gained popularity as a treatment modality of gonarthritis. Hyaluronic Acid is responsible for the elasticity and viscosity of the synovial fluid, protecting the joint. Biopsy studies show that besides the gain in pain and function, viscosupplementation may lead to structural changes of the cartilage. Currently there are several studies on the effect of intra-articular injection of hyaluronic acid in gonarthritis. There is not, however, a consensus on the best method. Regarding the substance to be injected, corticosteroids alone exhibit rapid results, but poor durability. Viscosupplementation shows more consistent results. However, especially when using derivatives with higher molecular weight hyaluronan, there is a significant number of patients that present an acute synovial reaction to viscosupplementation specially in the first cycle of three injections. The association triamcinolone injection with hyaluronic acid decreases the complaints in the first month of treatment. Our objective is to evaluate what is the best dosage of viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide by comparing two groups of patients with knee OA, the first with a single application of 3 ampoules and second with three applications, one per week for three weeks. One hundred and four knee osteoarthritis (KOA) patients, which are currently in usual care for KOA at the Osteometabolic Group - Department of Orthopedics and Traumatology - University of São Paulo General Hospital - will be assessed. After signing the informed consent, participants will respond WOMAC™, Lequesne™, VAS, SF-36 (quality of life) and subjective IKDC (International Knee Documentation Committee). The questionnaires and functional assessment will be performed before the procedure infiltration with 1month, 3 months, 6 months and 1 year of intervention.Twenty Patients will be submitted to evaluation using force platform and balance NeuroCom ®, with the following tests: weight support during the squat (weight bearing squat (WBS), one-leg support (unilateral stance (U.S.), from sitting to foot (sit to stand - STS). Previously, at 1 month, 3 month, 6 month and 12 months after the intervention.

Frontal weight-bearing, profile and axial radiographs will be performed to radiologically assess participants' knees.Patients will be randomly divided into two groups of 54 patients, (groups 1 and 2). Patients in group 1 (G1) will be submitted to viscosupplementation with 1 application of 3 vials of hyaluronic acid 20mg/2ml (OSTEONIL®) and 1 ml (20 mg) triamcinolone, whereas group 2 patients will be submitted to viscosupplementation with three applications of one ampoule of hyaluronic acid 20 mg/2ml (one per week for three weeks), with the first application of OSTEONIL® with 1 ml (20 mg) triamcinolone.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 2

Patients from Group 2 will receive an intra-articular injection of 1 ampoule (2ml) of OSTEONIL®, on a weekly basis, for 3 weeks (total of 3 injections)

Group Type: EXPERIMENTAL

viscosupplementation 1+1+1

Intervention Type: DRUG

intra-articular injection with 1 ampoule per week for 3 weeks

Group 1

Patients from Group 1 will receive a single intra-articular injection of 3 ampoule (6ml) of OSTEONIL®

Group Type: EXPERIMENTAL

viscosupplementation 3 at once

Intervention Type: DRUG

single intra-articular injection with 3 ampoules

Interventions

viscosupplementation 1+1+1

intra-articular injection with 1 ampoule per week for 3 weeks

Intervention Type: DRUG

viscosupplementation 3 at once

single intra-articular injection with 3 ampoules

Intervention Type: DRUG

Other Intervention Names

1+1+1

Eligibility Criteria

Inclusion Criteria

• Met the American College of Rheumatology criteria for hip osteoarthritis
• No knee intraarticular injections in the last 6 months

Exclusion Criteria

• Severe reaction to the procedure

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcia U Rezende, Phd

Role: PRINCIPAL_INVESTIGATOR

FMUSP

Locations

Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAPPesq 0199/11

Identifier Type: -

Identifier Source: org_study_id