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OpenTrials
Completed

NCT Number: NCT01267214

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Siriraj Hospital, Faculty of Medicine, Mahidol university

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Hyaluronate (Hyalgan)

Drug

1% Sodium Hyaluronate in prefilled syringe

Osteotomy alone

Procedure

no injection

Primary outcomes

  1. Joint Space Width

    Time frame: 12 months

  2. Global assessment

    Time frame: 12 months

    assess by Patient and investigator

  3. WOMAC section A, B, C

    Time frame: 12 months

    Pain score

  4. Rescue medicine consumption

    Time frame: 12 months

    Diclofenac consumption

Sponsors and collaborators

Lead sponsor

TRB Chemedica

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Dec 28, 2010
Registry last updated
Nov 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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