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

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Sodium Hyaluronate (Hyalgan); Procedure: Osteotomy alone

• Registration Number: NCT01267214
• Lead Sponsor: TRB Chemedica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-02
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Study Completion: 2011-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-20
• Last Update Posted: 2012-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteotomy plus Hyalgan	Sodium Hyaluronate (Hyalgan)	Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Osteotomy alone	Osteotomy alone	-

Primary Outcome Measures

Name	Time	Method
Joint Space Width	12 months
WOMAC section A, B, C	12 months	Pain score
Rescue medicine consumption	12 months	Diclofenac consumption
Global assessment	12 months	assess by Patient and investigator

Trial Locations

Locations (1)

Siriraj Hospital, Faculty of Medicine, Mahidol university; 🇹🇭 Bangkok, Thailand