Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

Phase 2

Completed

Brief Summary: The aim of this study was to investigate the efficacy and safety of three weekly intraarticular injections of Hyaluronate (HA) in patients with unilateral ankle Osteoarthritis (OA).

Detailed Description: Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. Besides, no study to date has assessed whether balance function would change after HA injections in patients with ankle OA. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis. Pain, physical function and balance will be assessed as parameters for the effectiveness.

Recruitment & Eligibility

Inclusion Criteria

were 18 years of age or older, reported unilateral ankle pain for at least 6 months and had either reported no significant benefit from conservative treatment (rest, physical therapy, orthoses or pain medications etc.) or were unable to tolerate side effects of medications
ankle radiographs taken within 6 months were equivalent to grade 2 or 3 according to the Kellgren-Lawrence grading system (grade 2, definite osteophytes and possible narrowing of joint space; grade 3, moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and possible deformity of bone contour)22
had a current total AOS score (described below) of > 3 and < 9 (possible range, 0-10)
were normally active, not bedridden or confined to a wheelchair, and were able to walk 30 meters without the aid of a walker, crutches or cane
were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study
did not receive physical therapy or trial of shoe modifications or orthotics during the study period

Exclusion Criteria

pregnant and lactating women
bilateral ankle OA requiring treatment of both ankles
chronic ankle instability
lower leg trauma other than within the ankle
previous orthopedic surgery on the spine, hip or knee
presence of active joint infections of foot or ankle
previous surgery or arthroscopy on the ankle within 12 months
intraarticular steroid or HA injection in the treated ankle within the past 6 months
treatment with anticoagulants or immunosuppressives
history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
history of avian protein allergy
presence of other comorbidity (neoplasm, diabetes mellitus, paresis, recent trauma, etc) or poor health status that would interfere with the clinical assessments during the study

Arm && Interventions

Group	Intervention	Description
hyaluronate injection	sodium hyaluronate	All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months	baseline and 6 months	The AOS is a patient-rated, validated outcome measure that includes nine items on a pain subscale and nine items on a disability subscale. Using the AOS, a score of 0 represent no pain or disability and 10 represent worst pain or disability imaginable

Secondary Outcome Measures

Name	Time	Method
The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score	6 months	The American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score is a 100-point scale that devotes 40 points to pain, 50 points to function and 10 points to alignment. The maximum score of 100 points denotes no pain and normal function and alignment
Ankle Sagittal Range of Motion	6 months	Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.
Four Clinical Balance Tests	6 months	Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed " Up-and-Go" test (TUG) ,Berg Balance Scale (BBS)
the Level of Global Satisfaction Based on a 7-point Categorical Scale	6 months	The rating was based on a 7-point categorical scale weighted from completely satisfied, satisfied, somewhat satisfied, no change, somewhat unsatisfied, unsatisfied to completely unsatisfied.
Systemic and Local Adverse Events Recording	6 months	he occurrence of systemic and local adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded on a diary card
Rescue Acetaminophen Consumption	6 months	The use of all analgesic medication during the study period was recorded on a diary card by the patient.