Osteoarthritis
Conditions
Keywords
Ankle joint, Balance, Hyaluronic acid, Osteoarthritis
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.
Interventions
DRUGsodium hyaluronate
3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Sponsors
National Science and Technology Council, Taiwan
Kaohsiung Veterans General Hospital.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Participant flow
Recruitment details
Fifty patients fulfilled the inclusion criteria and consented to take part in this study.
Pre-assignment details
One patient withdrew his consent and one had a fear of injection prior to receiving the first injection. Two patients withdrew from the study before the third injection (one because of an unrelated intercurrent illness and one moving to another city).
Participants by arm
| Arm | Count |
|---|---|
| Hyaluronate Injection All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Hyaluronate Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age Continuous | 51.7 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment Taiwan | 50 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / — |
| serious Total, serious adverse events | 0 / — |
Outcome results
Primary
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
Population: The statistical analysis was done on completers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyaluronate Injection | Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months | 2.3 score on a scale | Standard Deviation 1.7 |
Comparison: Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patientsp-value: <0.05t-test, 2 sided
Secondary
Ankle Sagittal Range of Motion
Ankle sagittal ROM is the sum of ankle dorsiflexion and plantar flexion angles.
Time frame: 6 months
Secondary
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
Secondary
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
Secondary
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
Time frame: 6 months
Secondary
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
Secondary
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