Clinical trial NCT00918736: Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis
Official title: Hyaluronans in the Treatment of Ankle Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Ankle joint
Balance
Hyaluronic acid
Osteoarthritis
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-06-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score
timeFrame: 6 months
measure: Ankle Sagittal Range of Motion
timeFrame: 6 months
measure: Four Clinical Balance Tests
timeFrame: 6 months
measure: the Level of Global Satisfaction Based on a 7-point Categorical Scale
timeFrame: 6 months
measure: Systemic and Local Adverse Events Recording
timeFrame: 6 months
measure: Rescue Acetaminophen Consumption
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan
Study officials:
affiliation: Veterans General Hospital, Kaohsiung, Taiwan
name: Shu-Fen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salk RS, Chang TJ, D'Costa WF, Soomekh DJ, Grogan KA. Sodium hyaluronate in the treatment of osteoarthritis of the ankle: a controlled, randomized, double-blind pilot study. J Bone Joint Surg Am. 2006 Feb;88(2):295-302. doi: 10.2106/JBJS.E.00193.
citation: Sun SF, Chou YJ, Hsu CW, Hwang CW, Hsu PT, Wang JL, Hsu YW, Chou MC. Efficacy of intra-articular hyaluronic acid in patients with osteoarthritis of the ankle: a prospective study. Osteoarthritis Cartilage. 2006 Sep;14(9):867-74. doi: 10.1016/j.joca.2006.03.003. Epub 2006 Apr 24.
citation: Cohen MM, Altman RD, Hollstrom R, Hollstrom C, Sun C, Gipson B. Safety and efficacy of intra-articular sodium hyaluronate (Hyalgan) in a randomized, double-blind study for osteoarthritis of the ankle. Foot Ankle Int. 2008 Jul;29(7):657-63. doi: 10.3113/FAI.2008.0657.