Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01760577
• Date of registration: 30/12/2012
• Prospective Registration: No
• Primary sponsor: Kaohsiung Veterans General Hospital.
• Public title: Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis
• Scientific title: Comparing Effects of Intraarticular Botulinum Toxin A Versus Hyaluronate Plus Rehabilitation Exercise in Patients With Unilateral Ankle Osteoarthritis
• Date of first enrolment: May 2010
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01760577
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Shu-Fen Sun, MD
• Affiliation: Kaohsiung Veterans General Hospital, Taiwan

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankle Osteoarthritis

Intervention(s)

Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)

Drug: Hyalgan (Hyalgan, Fidia , Italy)

Primary Outcome(s)

Ankle Osteoarthritis Scale (AOS) score [Time Frame: at 6 months after the injection]

Secondary Outcome(s)

Visual analog scale (VAS) [Time Frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection]

AOFAS ankle/hindfoot score [Time Frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection.]

Timed " Up-and-Go" test (TUG) [Time Frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection]

Single-leg stance test (SLS) [Time Frame: pre-injection and at 2 weeks, 1 month, 3 months, and 6 months post injection]

adverse effects [Time Frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.]

global Patients satisfaction [Time Frame: at 2 weeks, 1 month, 3 months, and 6 months post injection.]

Secondary ID(s)

VGHKS100-061

Source(s) of Monetary Support

Please refer to primary and secondary sponsors