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

NCT ID: NCT01267214

Last Updated: 2012-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Osteotomy plus Hyalgan

Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28

Group Type EXPERIMENTAL

Sodium Hyaluronate (Hyalgan)

Intervention Type DRUG

1% Sodium Hyaluronate in prefilled syringe

Osteotomy alone

Group Type OTHER

Osteotomy alone

Intervention Type PROCEDURE

no injection

Interventions

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Sodium Hyaluronate (Hyalgan)

1% Sodium Hyaluronate in prefilled syringe

Intervention Type DRUG

Osteotomy alone

no injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TRB Chemedica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Siriraj Hospital, Faculty of Medicine, Mahidol university

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HGN-THA-08-01

Identifier Type: -

Identifier Source: org_study_id