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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-07-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee OA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients with symptomatic knee OA were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP (the combined-injection group) or a single injection of 3 ml PRP (the one-injection group).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study blinding was accomplished by having an investigator (blinded to the randomization and treatment) perform all the assessments

Study Groups

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the combined-injection group

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

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

All the injections were done by the same experienced physician using aseptic procedures.

the one-injection group

patients received a single injection of 3 ml PRP

Group Type ACTIVE_COMPARATOR

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

Intervention Type COMBINATION_PRODUCT

All the injections were done by the same experienced physician using aseptic procedures.

Interventions

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

All the injections were done by the same experienced physician using aseptic procedures.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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the one-injection group received a single injection of 3 ml PRP

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No