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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by TRB Chemedica:

Primary Outcome Measures:
  • 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


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

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267214

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

No publications provided

Responsible Party: TRB Chemedica
ClinicalTrials.gov Identifier: NCT01267214     History of Changes
Other Study ID Numbers: HGN-THA-08-01
Study First Received: December 23, 2010
Last Updated: November 20, 2012
Health Authority: Thailand: Ministry of Public Health

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

ClinicalTrials.gov processed this record on May 23, 2013