Back to resultsThe Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Sodium Hyaluronate (Hyalgan)
Osteotomy alone
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients between 35 and 65 years with primary knee OA with malalignment
- Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
- Malalignment is not exceed 15 degree (+,-)
- Pain on walking (15 m) ≥ 40 mm.
- Range of motion > 90 degree
- Evidence of adequate contraceptive methods in women of childbearing age
Exclusion Criteria:
- Previous surgery on affected knee
- Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
- Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
- Known or suspected infection of the affected joint
- Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
- Poor general health or other conditions which would make regular hospital attendance difficult
- Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
- Hypersensitivity to avian protein
- Ongoing or previous participation in a clinical study within the last 3 months
Sites / Locations
- Siriraj Hospital, Faculty of Medicine, Mahidol university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Osteotomy plus Hyalgan
Osteotomy alone
Arm Description
Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Outcomes
Primary Outcome Measures
Joint Space Width
Global assessment
assess by Patient and investigator
WOMAC section A, B, C
Pain score
Rescue medicine consumption
Diclofenac consumption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01267214
Brief Title
The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRB Chemedica
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Osteotomy plus Hyalgan
Arm Type
Experimental
Arm Description
Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Arm Title
Osteotomy alone
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate (Hyalgan)
Intervention Description
1% Sodium Hyaluronate in prefilled syringe
Intervention Type
Procedure
Intervention Name(s)
Osteotomy alone
Intervention Description
no injection
Primary Outcome Measure Information:
Title
Joint Space Width
Time Frame
12 months
Title
Global assessment
Description
assess by Patient and investigator
Time Frame
12 months
Title
WOMAC section A, B, C
Description
Pain score
Time Frame
12 months
Title
Rescue medicine consumption
Description
Diclofenac consumption
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 35 and 65 years with primary knee OA with malalignment
Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
Malalignment is not exceed 15 degree (+,-)
Pain on walking (15 m) ≥ 40 mm.
Range of motion > 90 degree
Evidence of adequate contraceptive methods in women of childbearing age
Exclusion Criteria:
Previous surgery on affected knee
Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
Known or suspected infection of the affected joint
Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
Poor general health or other conditions which would make regular hospital attendance difficult
Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
Hypersensitivity to avian protein
Ongoing or previous participation in a clinical study within the last 3 months
Facility Information:
Facility Name
Siriraj Hospital, Faculty of Medicine, Mahidol university
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients
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