Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Galderma

Status: Terminated

Conditions: Knee Osteoarthritis

Treatments: Device: PBS; Device: Durolane

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753830

35GA1203

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups, including a placebo group

Durolane

Experimental group

Description:

Single intraarticular injection of Durolane

Treatment:

Device: Durolane

PBS

Placebo Comparator group

Description:

Single intraarticular injection of PBS

Treatment:

Device: PBS