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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01267214

Enrollment

Registered

2010-12-28

Start date

2009-02-28

Completion date

2011-07-31

Last updated

2012-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DRUGSodium Hyaluronate (Hyalgan)

1% Sodium Hyaluronate in prefilled syringe

PROCEDUREOsteotomy alone

no injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026