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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686047
• Other study ID #: VGHKS14-CT8-12
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 11, 2016
• Last updated: February 14, 2016
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).
• Synvisc-One
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score	the change from baseline in the VAS pain score over 6 months.	at 1, 3 and 6 months postinjection	No
Secondary	WOMAC, Likert Scale	a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.	at 1, 3 and 6 months postinjection	No
Secondary	Lequesne index	Maximal score is 24 and higher scores represent worse function.	at 1, 3 and 6 months postinjection	No
Secondary	Timed Up-and-Go test (TUG)	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	at 1, 3 and 6 months postinjection	No
Secondary	Single-leg stance test (SLS)	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.	at 1, 3 and 6 months postinjection	No
Secondary	satisfaction based on a 100 mm VAS	Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS	at 1, 3 and 6 months postinjection	No
Secondary	The reported adverse events	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	at 1 week (safety records via phone call), 1, 3 and 6 months after the injection	Yes