nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis
NCT ID: NCT03182374
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
252 participants
INTERVENTIONAL
2017-07-14
2023-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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nSTRIDE APS
The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms.
nSTRIDE APS
Intra-articular injection
Synvisc-One
Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee
Synvisc-One
Intra-articular injection
Interventions
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nSTRIDE APS
Intra-articular injection
Synvisc-One
Intra-articular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
* A standing knee radiograph showing a K-L grade of 2 to 4
* Body mass index ≤ 40 kg/m2
* A qualifying WOMAC LK 3.1 pain subscale total score
* Signed an ethics committee-reviewed and approved informed consent form.
Exclusion Criteria
* Presence of symptomatic OA in the non-study knee at screening
* Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
* Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
* Presence of venous or lymphatic stasis in the index leg
* A history of local anesthetic allergy
* Previously documented failed treatment with nSTRIDE APS or Synvisc One
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Elizaveta Kon
Role: PRINCIPAL_INVESTIGATOR
Humanitas University Hospital
Locations
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AZ Monica
Antwerp, , Belgium
The Parker Institute, Frederiksberg Hospital
Copenhagen, , Denmark
Praxiskliniek für Unfallchirurgie und Orthopädie
Eisenach, , Germany
KniePraxis
Straubing, , Germany
Rizzoli Orthopedic Institute
Bologna, , Italy
The Istituto Clinico Humanitas
Milan, , Italy
Maastricht UMC+
Maastricht, , Netherlands
Oslo University Hospital - Olympiatoppen
Oslo, , Norway
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Ospedale Regionale di Lugano
Lugano, , Switzerland
Yildirim Beyazit University, School of Medicine
Ankara, , Turkey (Türkiye)
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, , United Kingdom
Royal Infirmary of Edinburgh - NHS Lothian
Edinburgh, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APSS-66-00
Identifier Type: -
Identifier Source: org_study_id
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