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

NCT01267214 — Phase 2, Completed, 40 participants, TRB Chemedica

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Registry	NCT01267214
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	TRB Chemedica (Industry)
Conditions	Knee Osteoarthritis
Interventions	Sodium Hyaluronate (Hyalgan), Osteotomy alone (Drug, procedure)
Dates	start 2009-02-01, primary completion 2010-02-01, completion 2011-07-01, first posted 2010-12-28, last updated 2012-11-21
Locations	1 site in Thailand

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Osteotomy plus Hyalgan	Experimental	Drug: Sodium Hyaluronate (Hyalgan)	Osteotomy at Week 0 Hyalgan injection at Week 2, 3, 4, 5, 6, 24, 25, 26, 27, 28
Osteotomy alone	Other	Procedure: Osteotomy alone

Sodium Hyaluronate (Hyalgan) (Drug): 1% Sodium Hyaluronate in prefilled syringe
Osteotomy alone (Procedure): no injection

+Outcome measures

Primary outcomes

Joint Space Width [12 months]
Global assessment [12 months]: assess by Patient and investigator
WOMAC section A, B, C [12 months]: Pain score
Rescue medicine consumption [12 months]: Diclofenac consumption

+Eligibility

Sex: All, ages: 35 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Siriraj Hospital, Faculty of Medicine, Mahidol university	Bangkok, Bangkok	Thailand