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

NCT01267214 | Completed Phase 2

• 1 other identifier: HGN-THA-08-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Joint Space Width

  12 months

• Global assessment

  assess by Patient and investigator

  12 months

• WOMAC section A, B, C

  Pain score

  12 months

• Rescue medicine consumption

  Diclofenac consumption

  12 months

Study Arms (2)

Osteotomy plus Hyalgan

EXPERIMENTAL

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

Drug: Sodium Hyaluronate (Hyalgan)

Osteotomy alone

OTHER

Procedure: Osteotomy alone

Interventions

Sodium Hyaluronate (Hyalgan) DRUG

1% Sodium Hyaluronate in prefilled syringe

Osteotomy plus Hyalgan

Osteotomy alone PROCEDURE

no injection

Osteotomy alone

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TRB Chemedica: lead

Study Sites (1)

Siriraj Hospital, Faculty of Medicine, Mahidol university

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; Osteotomy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2011
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

TH (1)