Comparison of Two Application Regimens for Viscosupplementation

NCT01824485 | Completed Phase 4 DMC

• 1 other identifier: CAPPesq 0199/11
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee; Viscosupplementation; Clinical Trial

Outcome Measures

Primary Outcomes (3)

• WOMAC

  Pain and function assessment with WOMAC questionaire

  6 months

• VAS

  Pain assessment with Visual Analogic Scale (VAS)

  6 months

• LEQUESNE

  Pain and function assessment with Lequesne questionaire

  6 months

Study Arms (2)

Group 2

EXPERIMENTAL

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)

Drug: viscosupplementation 1+1+1

Group 1

EXPERIMENTAL

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

Drug: viscosupplementation 3 at once

Interventions

viscosupplementation 1+1+1 DRUG

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

Also known as: 1+1+1

Group 2

viscosupplementation 3 at once DRUG

single intra-articular injection with 3 ampoules

Group 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe reaction to the procedure

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, 05410-000, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marcia U Rezende, Phd

  FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2013-09

Locations

BR (1)