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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267214
• Other study ID #: HGN-THA-08-01
• Status: Completed
• Phase: Phase 2
• First received: December 23, 2010
• Last updated: November 20, 2012
• Start date: February 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2012
• Source: TRB Chemedica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Sodium Hyaluronate (Hyalgan)
1% Sodium Hyaluronate in prefilled syringe

Procedure:
• Osteotomy alone
no injection

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Faculty of Medicine, Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
TRB Chemedica

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint Space Width		12 months	Yes
Primary	Global assessment	assess by Patient and investigator	12 months	Yes
Primary	WOMAC section A, B, C	Pain score	12 months	Yes
Primary	Rescue medicine consumption	Diclofenac consumption	12 months	Yes