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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:
ClinicalTrials.gov Identifier:
NCT01267214
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
  Purpose
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.

Condition Intervention Phase
Knee Osteoarthritis Drug: Sodium Hyaluronate (Hyalgan) Procedure: Osteotomy alone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by TRB Chemedica:

Primary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Osteotomy plus Hyalgan
Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Drug: Sodium Hyaluronate (Hyalgan)
1% Sodium Hyaluronate in prefilled syringe
Osteotomy alone Procedure: Osteotomy alone
no injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01267214


Locations
Thailand
Siriraj Hospital, Faculty of Medicine, Mahidol university
Bangkok, Thailand, 10700
Sponsors and Collaborators
TRB Chemedica
  More Information

Responsible Party: TRB Chemedica
ClinicalTrials.gov Identifier: NCT01267214     History of Changes
Other Study ID Numbers: HGN-THA-08-01
First Submitted: December 23, 2010
First Posted: December 28, 2010
Last Update Posted: November 21, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents