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

• Sponsor: TRB Chemedica (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01267214
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Sodium Hyaluronate (Hyalgan); Procedure: Osteotomy alone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Osteotomy alone	Procedure: Osteotomy alone; no injection

Outcome Measures

Primary Outcome Measures

1. Joint Space Width [12 months]

2. Global assessment [12 months]

   assess by Patient and investigator

3. WOMAC section A, B, C [12 months]

   Pain score

4. Rescue medicine consumption [12 months]

   Diclofenac consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital, Faculty of Medicine, Mahidol university	Bangkok		Thailand	10700

Sponsors and Collaborators

• TRB Chemedica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TRB Chemedica
• ClinicalTrials.gov Identifier: NCT01267214
• Other Study ID Numbers: HGN-THA-08-01
• First Posted: Dec 28, 2010
• Last Update Posted: Nov 21, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hyaluronic Acid

Study Results

No Results Posted as of Nov 21, 2012