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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.
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica
ClinicalTrials.gov Identifier:
NCT01267214
First received: December 23, 2010
Last updated: November 20, 2012
Last verified: November 2012

December 23, 2010
November 20, 2012
February 2009
February 2010   (final data collection date for primary outcome measure)
  • Joint Space Width [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Global assessment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    assess by Patient and investigator
  • WOMAC section A, B, C [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Pain score
  • Rescue medicine consumption [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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
Both
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01267214
HGN-THA-08-01
Not Provided
TRB Chemedica
TRB Chemedica
Not Provided
Not Provided
TRB Chemedica
November 2012

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