Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA

NCT05201040 | Completed

• 1 other identifier: RDCT-VSJK
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).

Conditions

Knee Osteoarthritis; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.

  The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.

  6 months post-treatment

Secondary Outcomes (11)

• The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment

  baseline, 2 weeks, 1 month, and 3 months post-treatment

• The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

  baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

• The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

  baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

• The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment

  baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

• The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

  baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment

Study Arms (2)

Mannitol-combined Hyaluronic acid

EXPERIMENTAL

2.0mL/syringe for one treatment

Device: JETKNEE Synovial Fluid Supplement

Normal saline

PLACEBO COMPARATOR

2.0mL for one treatment

Device: Normal saline

Interventions

JETKNEE Synovial Fluid Supplement DEVICE

2mL of JETKNEE Synovial Fluid Supplement

Mannitol-combined Hyaluronic acid

Normal saline DEVICE

2mL of normal saline

Normal saline

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 to 85 years of male or female.
• Meet the ACR diagnostic criteria, the target knee is confirmed with OA by radiographic images and Kellgren \&Lawrence (K-L) score of 2 to 3；
• Patients who still suffer from OA pain after receiving traditional non-drug therapy or general analgesic therapy within 6 months before the start of the study；
• The VAS pain score of target knee must be at least 3 cm within 1 week before the screening and if the other side of knee has OA at the same time, the VAS pain score should be less than 3 cm；
• Subject who has ability to understand the study purpose, comply with the study requirements, willing to stop all pain medications and physical therapy to the knees during the study and sign informed consent form (ICF).

You may not qualify if:

• The hip or ankle joints are diagnosed with OA, pain, or deformity；
• K-L score of 4 by radiographic image evaluation；
• The target knee has symptoms such as infection, redness, and swelling at the screening period and before treatment ；
• The target knee has received hyaluronic acid treatment within 6 months before included in the study；
• The target side has received lower limb surgery or knee operation with accompanied complications and significant mobility impairment within 6 months before the start of the study；
• The target knee has received treatments such as steroid injection, arthrocentesis or arthroscopic surgery within 3 months before screening；
• Patient with autoimmune disease (such as autoimmune collagenopathy, rheumatoid arthritis), malignant tumors, coagulation disorder, heart diseases, mental diseases…etc. which may cause higher risk to patients during participation in the study；
• Receiving orthopedic-related treatments which may affect the evaluation of the study；
• With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins；
• Pregnant, planning pregnancy or in breastfeeding females during the study period；
• Subject who cannot cooperate with the follow- ups；
• Other circumstances which judged to be unsuitable for participating in the study by the investigator.

Sponsors & Collaborators

• SciVision Biotech Inc.: lead

Study Sites (2)

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 21, 2022
• Study Start: November 15, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)