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

NCT04315103 | Completed Phase 2

• 1 other identifier: VGHKS107-152
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Knee OA

Keywords

Hyaluronan; Knee osteoarthritis; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• VAS pain score change from baseline

  . The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0=no pain to 100=worst possible pain)

  1,3 and 6 months

Secondary Outcomes (5)

• The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale)

  1,3 and 6 months

• Lequesne index

  1,3 and 6 months

• Single-leg stance test (SLS)

  1,3 and 6 months

• satisfaction

  1,3 and 6 months

• consumption of analgesics

  1,3 and 6 months

Study Arms (2)

the combined-injection group

EXPERIMENTAL

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

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

the one-injection group

ACTIVE COMPARATOR

patients received a single injection of 3 ml PRP

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

Interventions

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

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

Also known as: the one-injection group received a single injection of 3 ml PRP

the combined-injection group; the one-injection group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (2)

Department of Physical Medicine and Rehabilitation, Veterans General Hospital,

Kaohsiung City, 813, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

• Sun SF, Lin GC, Hsu CW, Lin HS, Liou IS, Wu SY. Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis. Sci Rep. 2021 Jan 8;11(1):140. doi: 10.1038/s41598-020-80333-x.

  PMID: 33420185 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Shu Fen Sun, MD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study blinding was accomplished by having an investigator (blinded to the randomization and treatment) perform all the assessments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director or Neurorehabilitation

Model Details: 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).

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 19, 2020
• Study Start: August 1, 2018
• Primary Completion: January 10, 2019
• Study Completion: July 10, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)