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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan
Kaohsiung City, Taiwan
Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 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
Time frame: baseline and 6 months
The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
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
Time frame: 6 months
Ankle Sagittal Range of Motion
Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.
Time frame: 6 months
Four Clinical Balance Tests
Single-leg stance test (SLS),The Functional Reach Test (FRT),Timed " Up-and-Go" test (TUG) ,Berg Balance Scale (BBS)
Time frame: 6 months
the Level of Global Satisfaction Based on a 7-point Categorical Scale
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.
Time frame: 6 months
Systemic and Local Adverse Events Recording
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
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Time frame: 6 months
Rescue Acetaminophen Consumption
The use of all analgesic medication during the study period was recorded on a diary card by the patient.
Time frame: 6 months