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

Phase 2

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Synvisc-One; Device: HYAJOINT Plus

• Registration Number: NCT02686047
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-14
• Last Update Submitted: 2016-02-14
• Study First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Synvisc-One group	Synvisc-One	The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
the HYAJOINT Plus group	HYAJOINT Plus	the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).

Primary Outcome Measures

Name	Time	Method
VAS pain score	at 1, 3 and 6 months postinjection	the change from baseline in the VAS pain score over 6 months.

Secondary Outcome Measures

Name	Time	Method
WOMAC, Likert Scale	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.
Lequesne index	at 1, 3 and 6 months postinjection	Maximal score is 24 and higher scores represent worse function.
Timed Up-and-Go test (TUG)	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
Single-leg stance test (SLS)	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.
satisfaction based on a 100 mm VAS	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
The reported adverse events	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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan