Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA

• ClinicalTrials.gov Identifier: NCT02686047
• Recruitment Status: Completed
• First Posted: February 19, 2016
• Last Update Posted: February 19, 2016
• Sponsor: Kaohsiung Veterans General Hospital.
• Information provided by (Responsible Party): Shu-Fen Sun, Kaohsiung Veterans General Hospital.

Study Description

Brief Summary:

Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Device: HYAJOINT Plus; Device: Synvisc-One	Phase 2; Phase 3

Detailed Description:

In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Efficacy and Safety of a Single Intraarticular Injection of a Novel Crosslinked Hyaluronic Acid (HYAJOINT Plus) With Synvisc-One for the Treatment of Knee Osteoarthritis: A Randomized-Controlled, Double-Blind Trial
• Study Start Date: September 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: the HYAJOINT Plus group; the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).	Device: HYAJOINT Plus; The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).; Other Name: Hyaluronic acid
Active Comparator: The Synvisc-One group; The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).	Device: Synvisc-One; The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Outcome Measures

Primary Outcome Measures :

1. VAS pain score [ Time Frame: at 1, 3 and 6 months postinjection ]
   the change from baseline in the VAS pain score over 6 months.

Secondary Outcome Measures :

1. WOMAC, Likert Scale [ Time Frame: at 1, 3 and 6 months postinjection ]
   a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
2. Lequesne index [ Time Frame: at 1, 3 and 6 months postinjection ]
   Maximal score is 24 and higher scores represent worse function.
3. Timed Up-and-Go test (TUG) [ Time Frame: at 1, 3 and 6 months postinjection ]
   a simple measurement of time in seconds for a person to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down
4. Single-leg stance test (SLS) [ Time Frame: at 1, 3 and 6 months postinjection ]
   by raising one foot up without touching it to the supported lower extremity with target knee OA and maintain balance for as long as possible.
5. satisfaction based on a 100 mm VAS [ Time Frame: at 1, 3 and 6 months postinjection ]
   Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS
6. The reported adverse events [ Time Frame: at 1 week (safety records via phone call), 1, 3 and 6 months after the injection ]
   based on adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy

• average pain on knee movement of 30 mm or greater on a 100-mm VAS

  • grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months
  • Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

• previous orthopedic surgery on the spine or lower limbs
• disabling OA of either hip or foot
• knee instability, clinical apparent joint effusion or marked valgus/varus deformity
• known allergy to avian proteins or HA products
• women ascertained or suspected pregnancy or lactating
• intraarticular injections within the past 6 months
• infections or skin diseases around the target knee
• any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Contacts and Locations

Locations

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

More Information

• Responsible Party: Shu-Fen Sun, MD, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT02686047
• Other Study ID Numbers: VGHKS14-CT8-12
• First Posted: February 19, 2016
• Last Update Posted: February 19, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Shu-Fen Sun, Kaohsiung Veterans General Hospital.:

Knee osteoarthritis; Hyaluronic acid; Viscosupplementation

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hyaluronic Acid; Hylan; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents