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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT00918736
First received: March 16, 2009
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

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).


Condition Intervention Phase
Osteoarthritis
Drug: sodium hyaluronate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyaluronans in the Treatment of Ankle Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • Change From Baseline in the Ankle Osteoarthritis Scale (AOS) Score at 6 Months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Ankle Sagittal Range of Motion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Four Clinical Balance Tests [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • the Level of Global Satisfaction Based on a 7-Point Categorical Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Systemic and Local Adverse Events Recording [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Rescue Acetaminophen Consumption [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hyaluronate injection
All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Drug: sodium hyaluronate
3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
Other Name: sodium hyaluronate

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918736

Locations
Taiwan
Department of Physical Medicine and Rehabilitation, Veterans General Hospital, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
National Science Council, Taiwan
Investigators
Principal Investigator: Shu-Fen Sun, MD Veterans General Hospital, Kaohsiung, Taiwan
  More Information

Publications:
Responsible Party: Shu-Fen Sun, Kaohsiung Veteran General Hospital
ClinicalTrials.gov Identifier: NCT00918736     History of Changes
Other Study ID Numbers: NSC96-2314-B-075B-006
Study First Received: March 16, 2009
Results First Received: March 16, 2009
Last Updated: June 11, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:
Ankle joint
Balance
Hyaluronic acid
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 22, 2014