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The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 28, 2010
Last Update Posted: November 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TRB Chemedica
December 23, 2010
December 28, 2010
November 21, 2012
February 2009
February 2010   (Final data collection date for primary outcome measure)
  • Joint Space Width [ Time Frame: 12 months ]
  • Global assessment [ Time Frame: 12 months ]
    assess by Patient and investigator
  • WOMAC section A, B, C [ Time Frame: 12 months ]
    Pain score
  • Rescue medicine consumption [ Time Frame: 12 months ]
    Diclofenac consumption
Same as current
Complete list of historical versions of study NCT01267214 on ClinicalTrials.gov Archive Site
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The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
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The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Drug: Sodium Hyaluronate (Hyalgan)
    1% Sodium Hyaluronate in prefilled syringe
  • Procedure: Osteotomy alone
    no injection
  • Experimental: Osteotomy plus Hyalgan
    Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
    Intervention: Drug: Sodium Hyaluronate (Hyalgan)
  • Osteotomy alone
    Intervention: Procedure: Osteotomy alone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2011
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients between 35 and 65 years with primary knee OA with malalignment
  2. Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
  3. Malalignment is not exceed 15 degree (+,-)
  4. Pain on walking (15 m) ≥ 40 mm.
  5. Range of motion > 90 degree
  6. Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

  1. Previous surgery on affected knee
  2. Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
  3. Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
  4. Known or suspected infection of the affected joint
  5. Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
  6. Poor general health or other conditions which would make regular hospital attendance difficult
  7. Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
  8. Hypersensitivity to avian protein
  9. Ongoing or previous participation in a clinical study within the last 3 months
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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TRB Chemedica
TRB Chemedica
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TRB Chemedica
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP