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Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01753830
Recruitment Status : Terminated (Study terminated early due to decision by sponsor)
First Posted : December 20, 2012
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Brief Summary:
The purpose of the study is to determine whether a single intra-articular injection of Durolane is superior to a single injection of PBS for the relief of joint pain in patients with osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Durolane Device: PBS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Durolane
Single intraarticular injection of Durolane
Device: Durolane
Placebo Comparator: PBS
Single intraarticular injection of PBS
Device: PBS



Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score [ Time Frame: Up to 30 weeks ]

Secondary Outcome Measures :
  1. Outcome Measures in Rheumatology Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) Response [ Time Frame: Up to 30 weeks ]
  2. WOMAC Physical Function score [ Time Frame: Up to 30 weeks ]
  3. Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life questionnaire [ Time Frame: Up to 30 weeks ]
  4. Physical Global Evaluation [ Time Frame: Up to 30 weeks ]
  5. Patient Global Evaluation [ Time Frame: Up to 30 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) ≤ 35 kg/m2
  • Symptomatic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753830


  Show 25 Study Locations
Sponsors and Collaborators
Q-Med AB
Investigators
Principal Investigator: Nebojsa Skrepnik, MD, PhD Tucson Orthopaedic Institute

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01753830     History of Changes
Other Study ID Numbers: 35GA1203
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Q-Med AB:
Double-blind
Randomized
Intraarticular injection
Hyaluronic acid
Placebo
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases