Trial | NCT01267214  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hyaluronic acid ...

  • Study Participants

    40
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.
Study Started
Feb 28
2009
Primary Completion
Feb 28
2010
Study Completion
Jul 31
2011
Last Update
Nov 21
2012
Estimate

Drug Sodium Hyaluronate (Hyalgan)

1% Sodium Hyaluronate in prefilled syringe

Procedure Osteotomy alone

no injection

Osteotomy plus Hyalgan Experimental

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

Osteotomy alone Other

Criteria 

Inclusion Criteria:

Patients between 35 and 65 years with primary knee OA with malalignment
Mild to moderate OA of grade II or III severity on the Kellgren-Lawrence scale with require treatment by osteotomy
Malalignment is not exceed 15 degree (+,-)
Pain on walking (15 m) ≥ 40 mm.
Range of motion > 90 degree
Evidence of adequate contraceptive methods in women of childbearing age

Exclusion Criteria:

Previous surgery on affected knee
Previous intraarticular intervention within the last 3 months (eg. Steroid, anaesthetic, Sodium hyaluronate)
Oral SYSADOA treatment (chondroitin, glucosamine, diacerein) within 2 months prior to study start
Known or suspected infection of the affected joint
Painful knee condition due to another cause than chondral lesions, such as Sudeck's atrophy, intraarticular neoplasm, pigmented villonodular synovitis, chondromatosis
Poor general health or other conditions which would make regular hospital attendance difficult
Ascertained hypersensitivity to any component used in the study (eg. Hyaluronic acid, diclofenac, morphine, omeprazole and paracetamol)
Hypersensitivity to avian protein
Ongoing or previous participation in a clinical study within the last 3 months
No Results Posted