a Single HYAJOINT Plus Combined With a Single PPR Versus a Single PRP for Knee OA

Kaohsiung Veterans General Hospital

Status and phase: Completed; Phase 2

Conditions: Knee OA

Treatments: Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP

Study type: Interventional

Funder types: Other

Identifiers

NCT04315103

VGHKS107-152

Details and patient eligibility

About

Intraarticular hyaluronan or platelet-rich plasma (PRP) is each effective in the treatment for knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP for knee OA remained unclear. This study aimed to investigate the efficacy of a single intraarticular hyaluronan (HYAJOINT Plus) combined with a single PRP versus a single intraarticular PRP in patients with knee OA.

Full description

Intraarticular HA or PRP has been used for knee OA for years. Combined HA and PRP has not been widely used for OA because of lack of clinical evidence. Based on in vitro and animal studies, combining HA and PRP may benefit from their dissimilar biological mechanisms for tissue repair and have potentials to synergistically promote cartilage regeneration, inhibit OA inflammation, modulate the disease process, and improve joint homeostasis in OA. Combination of HA and PRP has much potential for the treatment of OA, but the clinical evidence of this combination remains unclear. The purpose of this study was to investigate the efficacy and safety of combined a single crosslinked HA (HYAJOINT Plus) with a single PRP versus a single PRP alone in patients with knee OA.

Enrollment: 85 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 20-75 years;Symptomatic knee OA > 6 months despite conservative treatment such as oral analgesics, NSAIDs and/or physical therapy;Kellgren-Lawrence grades 2 knee OA on radiographs taken within the previous 6 months;Average pain at walking > 30 mm on a 100-mm visual analog scale (VAS);Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee< 30 mm.

Exclusion criteria

• Previous orthopedic surgery on the spine or lower limbs Disabling OA of either hip or foot Knee instability, apparent joint effusion or marked valgus/varus deformity Known allergy to hyaluronan products Women ascertained or suspected pregnancy or lactating Intraarticular injections into the knee in the past 6 months Any specific medical conditions (rheumatoid arthritis, active infections, severe cardiovascular diseases, autoimmune diseases, hemiparesis, neoplasm, etc.) that would interfere with the assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

the combined-injection group

Experimental group

Description:

patients received a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP

Treatment:

Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP

the one-injection group

Active Comparator group

Description:

patients received a single injection of 3 ml PRP

Treatment:

Combination Product: a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP