Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Galderma R&D75 enrolled

Overview

The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

DurolaneDEVICE

4.5 mL

PBSDEVICE

4.5 mL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index (BMI) ≤ 35 kg/m2 * Symptomatic osteoarthritis (OA) of the knee * K L severity grade 1 or 2 * If bilateral OA, contralateral knee K L severity grade 0 or 1 Exclusion Criteria: * Has clinically apparent tense effusion of the index knee * Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months * Has any painful orthopedic disorders of the back or hip * Has a joint disorder other than osteoarthritis in the index knee

Locations (25)

Unnamed facility

Anniston, Alabama, United States

Unnamed facility

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Average Change in WOMAC VAS Pain Score From Week 6 to Week 30

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.

Time frame: Up to 30 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.