Overview

Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Hyaluronic Acid
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
Inclusion Criteria:

- an age of 20-85 years with diagnosis of ankle osteoarthritis

- unilateral ankle pain that had lasted for at least 6 months, with no significant
benefit from conservative treatment or with an inability to tolerate the side effects
of medications

- ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence
grading system

- a current total Ankle Osteoarthritis Scale (AOS) score of >3 and < 9 (possible range,
0-10)

- a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able
to walk 30 meters without the aid of a walker, crutches or cane

- no changes in shoes or orthotic devices during the study period.

Exclusion Criteria:

- pregnancy or lactation in women

- lower leg trauma other than ankle trauma

- previous surgery involving the spine, hip or knee

- the presence of an active joint infections of foot or ankle

- previous surgery or arthroscopy on the ankle within 12 months

- history of chicken or egg allergy

- intraarticular steroid or hyaluronate injection in the treated ankle within the
previous 6 months

- treatment with anticoagulants or immunosuppressives

- a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy

- the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or
recent trauma) or poor health status that would interfere with the clinical
assessments during the study.