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

TRB Chemedica

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Drug: Sodium Hyaluronate (Hyalgan); Procedure: Osteotomy alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01267214

HGN-THA-08-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Osteotomy plus Hyalgan

Experimental group

Description:

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

Treatment:

Drug: Sodium Hyaluronate (Hyalgan)

Osteotomy alone

Other group

Treatment:

Procedure: Osteotomy alone