Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)

NCT01185444 | Completed Phase 2 DMC

• 1 other identifier: VGHKS97-CT9-12
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with knee osteoarthritis. The treatment effects can last for 6 months.

Conditions

Hyaluronate; Osteoarthritis; Knee

Keywords

Knee Balance; Hyaluronate; Osteoarthritis; Viscosupplementation

Outcome Measures

Primary Outcomes (1)

• visual analog scale

  The patient rated the intensity of pain with regard to average pain on knee movement over the previous week using a 10-cm horizontal VAS (10-cm line; 0= no pain to 10= worst imaginable pain)

  6 months after the third injection

Secondary Outcomes (3)

• Lequesne index

  6 months after the third injection

• Timed " Up-and-Go" test

  6 months after the third injection.

• the level of global satisfaction

  6 months after the third injection.

Study Arms (2)

Hya-Joint

EXPERIMENTAL

The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.

Procedure: Hya-Joint

Hyalgan

ACTIVE COMPARATOR

the control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.

Procedure: Hyalgan

Interventions

Hya-Joint PROCEDURE

The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.

Hya-Joint

Hyalgan PROCEDURE

The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.

Hyalgan

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) age 40 years or older, presence of a primary knee OA with knee pain for at least 6 months despite conservative treatment (rest, physical therapy, orthoses or pain medications etc.); (2) had average pain on knee movement of at least 3 cm on a 10-cm VAS; (3) had a current Lequesne index score (described below) \>7 (possible range, 0-24); (4) were willing to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (except for rescue medication) for the duration of the study; and (5) were willing to not receive physical therapy or trial of shoe modifications or orthoses during the study period.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Veterans General Hospital,

Kaohsiung City, 813, Taiwan

Location

Related Publications (2)

• Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Tsai SL, Chou YJ, Hsu YW, Huang CM, Wang YL. Hyaluronate improves pain, physical function and balance in the geriatric osteoarthritic knee: a 6-month follow-up study using clinical tests. Osteoarthritis Cartilage. 2006 Jul;14(7):696-701. doi: 10.1016/j.joca.2006.01.010. Epub 2006 Mar 6.

  PMID: 16520067 BACKGROUND

• Adams ME, Atkinson MH, Lussier AJ, Schulz JI, Siminovitch KA, Wade JP, Zummer M. The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone. Osteoarthritis Cartilage. 1995 Dec;3(4):213-25. doi: 10.1016/s1063-4584(05)80013-5.

  PMID: 8689457 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Shu-Fen Sun, MD

  Veterans General Hospital, Kaohsiung;National Yang-Ming University School of Medicine, Taiwan

  PRINCIPAL INVESTIGATOR

• Chien-Wei Hsu, MD

  Department of Internal Medicine, Kaohsiung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Hsien-Pin Sun, MD

  Cheng Ching Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Hung-Ju Li, MS

  Institute of Statistics, National University of Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

• Jue-Long Wang, MD

  Kaohsiung Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 20, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 20, 2010

Record last verified: 2008-12

Locations

TW (1)