Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT01543737
• Date of registration: 20/02/2012
• Prospective Registration: No
• Primary sponsor: Bioventus LLC
• Public title: Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
• Scientific title: Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
• Date of first enrolment: February 2012
• Target sample size: 290
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01543737
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France, Monaco

Contacts

• Name: Thierry Conrozier, MD
• Affiliation: Lyon University Hospital (HCL)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 40 and < 85

- Tibiofemoral osteoarthritis of the knee according to the American College of
Rheumatology clinical criteria, in the Kellgren-Lawrence (KL) stages II-III,
confirmed by radiology (< 3 months)

- Unilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1
scale), assessed over the previous 24 hours on a scale of 0 to 10: Pain when walking:
= 3 and < 8

- Bilateral osteoarthritis of the knee, if pain in the other knee is < 3 (10-point
numerical scale)

- Patient: outpatient, capable of walking 50 metres without a walking stick, crutches
or a walker, capable of reading, understanding, signing and dating the patient
information sheet

- Patient with social security cover

Exclusion Criteria:

- Osteoarthritis of the knee in Kellgren-Lawrence (KL) stages I and IV

- Bilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1
scale), assessed on a scale of 0 to 10: Pain when walking > 3, in both knees

- Predominant symptomatic patellofemoral osteoarthritis of the knee

- Congestive manifestation of osteoarthritis of the knee defined according to the Knee
Osteoarthritis Flare-Ups Score (KOFUS) criteria

- Last viscosupplementation of the affected knee < 6 months before, last injection of
corticosteroids < 2 months before

- Known hypersensitivity to avian proteins and hyaluronic acids;

- History of joint replacement or major surgery in the affected knee in the last six
months

- History of arthroscopy or surgery in the affected knee in the last three months

- Symptomatic hip disease on the same side or other side of the body

- Joint replacement or any other surgery planned in the next six months

- History of septic arthritis of the affected knee

- Skin complaint affecting the knee at the injection site

- Haemorrhagic disease contraindicating, in the doctor's opinion, any intra-articular
injection

- In order to respect the pragmatic nature of the study:

- Any medical and / or pathological condition that, in the investigator's opinion,
makes the subject unsuitable for inclusion

- Any medical and / or pathological condition that, in the investigator's opinion,
would be a contraindication for an intra-articular injection

- Any other complaint that, in the investigator's opinion, would impede the assessment
of the effectiveness of the affected knee

- Any treatment administered to the patient that may interfere with the interpretation
of the study results

- Use of glucocorticosteroids (except inhaled corticosteroids) during the previous
month

- Treatment with diacerein, avocado and soya unsaponifiables, glucosamine sulphate or
chondroitin sulphate, started in the previous 3 months, or irregular doses over the
previous 3 months

- Hard of hearing (not being able to follow a telephone conversation properly)

- Patient without a telephone

- Pregnant women or nursing mothers

- Participation in other clinical studies, within 30 days before inclusion



Age minimum: 40 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Knee Osteoarthritis

Intervention(s)

Device: 3ml hyaluronic acid (DUROLANE)

Device: 2ml hyaluronic acid, (HYALGAN)

Primary Outcome(s)

Patients assessment of WOMAC A1 pain when walking [Time Frame: 24 weeks]

Secondary Outcome(s)

Patients assessment of WOMAC C function [Time Frame: 24 weeks]

Minimal Clinically Important Improvement (MCII) [Time Frame: 24 weeks]

Patient global assessment [Time Frame: 24 weeks]

Adverse events observed or spontaneously reported by patients for each treatment [Time Frame: 24 weeks]

OMERACT-OARSI responder rate [Time Frame: 24 weeks]

Patients assessment of WOMAC A pain [Time Frame: 24 weeks]

Patient Acceptable Symptom State (PASS) [Time Frame: 24 weeks]

Secondary ID(s)

SNOF EC 01/2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors