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Durolane Versus Methylprednisolone in Knee Osteoarthritis

Information source: Q-Med AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Knee Osteoarthritis

Intervention: Durolane is a device, methylprednisolone in a drug (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Q-Med AB


The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.

Clinical Details

Official title: Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain level and responder rate

Secondary outcome:

WOMAC stiffness score

WOMAC physical function

Functional assessment

Safety assessment (Adverse Events)


Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Subject (female or male) 35-80 years of age

- Unilateral knee pain

- Radiographic evidence of OA

- WOMAC pain score of 7-17

- Subject normally active

- Subject has attempted but not responded adequately to previous non-pharmacological


- Subject cooperative and able to communicate effectively with the investigators;

- Body mass index ≤ 40 kg/m2;

- Signed informed consent obtained.

Exclusion Criteria:

- Knee effusion

- Contralateral knee OA

- Clinically significant joint pain from joints other than the knee

- Previous intra-articular steroid injection into the study knee within the last 3


- Previous intra-articular HA injection into the study knee within the last 9 months;

- Previous allergic type reaction to a HA product, a steroid, or lidocaine/related


- Treatment with analgesics other than paracetamol (acetaminophen) (including topical

agents for the knee) within 5 half lives of the drug prior to the baseline visit;

- Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3


- Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months

- Change in physical therapy for the knee within the last three months

- Arthroscopy or other surgical procedure in the study knee within the past 12 months;

- Any planned arthroscopy or other surgical procedure during the study period;

- Previous history or presence of active septic arthritis

- Active skin disease or infection in the area of the injection site;

- Systemic active inflammatory condition or infection

- Bleeding diathesis or use of anticoagulants

- Current uncontrolled diabetes mellitus;

- Any medical condition that in the opinion of the investigator makes the subject

unsuitable for inclusion

- Pregnant or breastfeeding woman or woman of childbearing potential not practicing

adequate contraception;

- Involvement in other clinical trials

Locations and Contacts

Läkargruppen Kristinelund, Göteborg 411 37, Sweden

Ortopediska huset, Johanneshov 121 77, Sweden

Läkarhuset Ellenbogen, Malmö 211 36, Sweden

Ortopediska huset, Stockholm 11360, Sweden

Kings College Hospital - Department of Rheumatology, London SE5 9RS, United Kingdom

Newcastle University Clinical Research FacilityRoyal Victoria Infirmary, Newcastle NE1 4LP, United Kingdom

Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics, Oswestry SY10 7AG, United Kingdom

Southampton General Hospital - MRC Epidemiology Resource Center, Southampton SO16 6YD, United Kingdom

Alberta Bone & Joint Health Institute, Calgary, Alberta T2P 3C5, Canada

Nexus Clinical Research, St John´s, Newfoundland and Labrador A1B 3E1, Canada

Orthopaedic & Sport Medicine Institute of Nova Scotia, Halifax, Nova Scotia B3H 4M2, Canada

Dr. Wilson, Lunenburg, Nova Scotia B0J2C0, Canada

QEII Health Sciences Centre-New Halifax Infirmary, Halifax, Ontario B3H 3A7, Canada

Charlton Medical Centre, Hamilton, Ontario L8N 1Y2, Canada

MAC Research Inc., Hamilton, Ontario L8N 2B6, Canada

Fowler Kennedy Sport Medicine Clinic, London, Ontario N6A 3K7, Canada

Credit Valley Rheumatology, Mississauga, Ontario L5M 2V8, Canada

The Arthritis Program Research Group, Newmarket, Ontario L3Y 3R7, Canada

Dr. Dobson, Peterborough, Ontario K9J 6X2, Canada

Sport C.A.R.E. Women's College Hospital, Toronto, Ontario M5S 1B2, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Centre de Rhumatologie St-Louis, Saint-Foy, Quebec G1W4R4, Canada

Saskatoon Osteoporosis Centre, Saskatoon, Saskatchewan S7K 0H6, Canada

Additional Information

Starting date: March 2007
Last updated: November 6, 2012

Page last updated: August 23, 2015

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