NCT01209364

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
442

participants targeted

Target at P50-P75 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Mar 2007

Geographic Reach
3 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2007

Enrollment Period

10 months

First QC Date

September 20, 2010

Last Update Submit

August 24, 2022

Conditions

Knee Osteoarthritis

Keywords

comparativerandomizeddouble-blindnon-inferiorknee OA

Outcome Measures

Primary Outcomes (1)

  • Pain level and responder rate

    up to 12 weeks

Secondary Outcomes (4)

  • WOMAC stiffness score

    26 weeks blinded phase + 26 weeks OLE

  • WOMAC physical function

    26 weeks blinded phase + 26 weeks OLE

  • Functional assessment

    26 weeks blinded phase + 26 weeks OLE

  • Safety assessment (Adverse Events)

    26 weeks blinded phase + 26 weeks OLE

Study Arms (2)

Durolane

EXPERIMENTAL

intraarticular hyaluronic acid

Device: Durolane is a device, methylprednisolone in a drug

methylprednisolone

ACTIVE COMPARATOR

intraarticular injection

Device: Durolane is a device, methylprednisolone in a drug

Interventions

Durolane is a device, methylprednisolone in a drugDEVICE

single intraarticular injection

Also known as: Durolane and Depo-Medrol are the brand names
Durolanemethylprednisolone

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 therapy(ies);
  • Subject cooperative and able to communicate effectively with the investigators;
  • Body mass index ≤ 40 kg/m2;
  • Signed informed consent obtained.

You may not qualify if:

  • 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 months;
  • 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 anesthetics;
  • 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 months;
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Alberta Bone & Joint Health Institute

Calgary, Alberta, T2P 3C5, Canada

Location

Nexus Clinical Research

St. John's, Newfoundland and Labrador, A1B 3E1, Canada

Location

Orthopaedic & Sport Medicine Institute of Nova Scotia

Halifax, Nova Scotia, B3H 4M2, Canada

Location

Dr. Wilson

Lunenburg, Nova Scotia, B0J2C0, Canada

Location

QEII Health Sciences Centre-New Halifax Infirmary

Halifax, Ontario, B3H 3A7, Canada

Location

Charlton Medical Centre

Hamilton, Ontario, L8N 1Y2, Canada

Location

MAC Research Inc.

Hamilton, Ontario, L8N 2B6, Canada

Location

Fowler Kennedy Sport Medicine Clinic

London, Ontario, N6A 3K7, Canada

Location

Credit Valley Rheumatology

Mississauga, Ontario, L5M 2V8, Canada

Location

The Arthritis Program Research Group

Newmarket, Ontario, L3Y 3R7, Canada

Location

Dr. Dobson

Peterborough, Ontario, K9J 6X2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Sport C.A.R.E. Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Centre de Rhumatologie St-Louis

Saint-Foy, Quebec, G1W4R4, Canada

Location

Saskatoon Osteoporosis Centre

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Läkargruppen Kristinelund

Gothenburg, 411 37, Sweden

Location

Ortopediska huset

Johanneshov, 121 77, Sweden

Location

Läkarhuset Ellenbogen

Malmo, 211 36, Sweden

Location

Ortopediska huset

Stockholm, 11360, Sweden

Location

Kings College Hospital - Department of Rheumatology

London, SE5 9RS, United Kingdom

Location

Newcastle University Clinical Research FacilityRoyal Victoria Infirmary

Newcastle, NE1 4LP, United Kingdom

Location

Robert Jones and Agnes Hunt Orthopaedic & District Hospital - Institute of Orthopaedics

Oswestry, SY10 7AG, United Kingdom

Location

Southampton General Hospital - MRC Epidemiology Resource Center

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • Leighton R, Akermark C, Therrien R, Richardson JB, Andersson M, Todman MG, Arden NK; DUROLANE Study Group. NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014 Jan;22(1):17-25. doi: 10.1016/j.joca.2013.10.009. Epub 2013 Nov 1.

    PMID: 24185114DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 27, 2010

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

November 1, 2008

Last Updated

August 25, 2022

Record last verified: 2007-08

Locations

CA(15)GB(4)SE(4)