Efficacy of 3 Weekly Injections of Hyaluronate in Patients With Ankle Osteoarthritis

NCT00918736 | Completed Phase 2 Results DMC

• 1 other identifier: NSC96-2314-B-075B-006
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis

Keywords

Ankle joint; Balance; Hyaluronic acid; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 6 months

Secondary Outcomes (6)

• The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score

  6 months

• Ankle Sagittal Range of Motion

  6 months

• Four Clinical Balance Tests

  6 months

• the Level of Global Satisfaction Based on a 7-point Categorical Scale

  6 months

• Systemic and Local Adverse Events Recording

  6 months

Study Arms (1)

hyaluronate injection

EXPERIMENTAL

All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.

Drug: sodium hyaluronate

Interventions

sodium hyaluronate DRUG

3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.

hyaluronate injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, 813, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 16452740 BACKGROUND

• 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.

  PMID: 16635582 BACKGROUND

• 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.

  PMID: 18785414 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

One limitation includes the absence of a control group, thus the placebo effects associated with joint injections were not investigated.

Results Point of Contact

• Title: Shu-Fen Sun
• Organization: Veterans General Hospital, Kaohsiung, Taiwan

sfsun.tw@yahoo.com.tw

886-73422121

Study Officials

• Shu-Fen Sun, MD

  Veterans General Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: June 11, 2009
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 17, 2009
• Results First Posted: June 11, 2009

Record last verified: 2009-06

Locations

TW (1)