Clinical trial NCT02686047: Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Hyaluronic acid
Viscosupplementation
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: VAS pain score
timeFrame: at 1, 3 and 6 months postinjection
Secondary outcomes:
measure: WOMAC, Likert Scale
timeFrame: at 1, 3 and 6 months postinjection
measure: Lequesne index
timeFrame: at 1, 3 and 6 months postinjection
measure: Timed Up-and-Go test (TUG)
timeFrame: at 1, 3 and 6 months postinjection
measure: Single-leg stance test (SLS)
timeFrame: at 1, 3 and 6 months postinjection
measure: satisfaction based on a 100 mm VAS
timeFrame: at 1, 3 and 6 months postinjection
measure: The reported adverse events
timeFrame: at 1 week (safety records via phone call), 1, 3 and 6 months after the injection
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References: