Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Device: Durolane; Device: PBS

• Registration Number: NCT01753830
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Disposition First Submitted: 2016-07-15
• Disposition First Submitted QC: 2016-07-15
• Disposition First Posted: 2016-07-19
• Status Verified: 2020-09
• Results First Submitted: 2020-09-04
• Results First Submitted QC: 2020-09-29
• Results First Posted: 2020-09-30
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durolane	Durolane	Single intraarticular injection of Durolane
PBS	PBS	Single intraarticular injection of PBS

Primary Outcome Measures

Name	Time	Method
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30	Up to 30 weeks	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.