The Safety and Efficacy of Single IA-HA Injection in Patients With Knee Osteoarthritis: A Prospective Study

NCT04577521 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study was planned to carried out among the patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients clinic to evaluate the effectiveness and safety of viscosupplementation with intra-articular hyaluronic acid injection.

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (2)

• Change from Baseline to 3 Months and 6 Months in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.

  Baseline, 3 Months and 6 Months

• Overview of Adverse Events (AE)

  An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study device until the end of study period). Category "AE" included participant with both serious and non-serious AE.

  Through study completion, an average of 6 Months

Secondary Outcomes (1)

• Change in quality of life measured by SF-36 questionnaire (Short Form Health Survey questionnaire)

  Baseline,3 Months and 6 Months

Interventions

BioVisc Ortho Single DEVICE

BioVisc Ortho Single consisted of a prefilled syringe containing 90 mg/3 mL of IA-HA and is an injectable-grade HA from a biofermentation origin. Biovisc ortho single prefilled syringes are intended for single-use only, and the entire content of the syringe was injected into the target joint.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients clinic

You may qualify if:

• Patients Age should not be less than 18 years.
• Patients must be able to understand and follow the study procedures and must provide written informed consent.
• Radiologically Grade II or III osteoarthritis of knee according to the Kellgren and Lawrence classification.
• Mild to moderate documented diagnosis of knee osteoarthritis that fulfill the ACR (American College of Rheumatology) criteria.
• Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or combination of these symptoms) of knee osteoarthritis for at least 3 months prior to screening. If bilateral knee pain is present, the more painful knee will be selected.
• Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain. However patients will be allowed to use only acetaminophen or aspirin as a rescue pain medication during the study period. The patients must abstain from medication use 24 hours prior to any study visit.

You may not qualify if:

• Patients with secondary osteoarthritis of the knee according to ACR criteria.
• Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception.
• Patients unable to stay in the study for 6 months, non- cooperating, not able to understand
• Patients having previously undergone surgery on target knee, including arthroscopy.
• Patients with neurological deficit in the lower extremities, with primary inflammatory joint disease, intra-articular tumours.
• Any severe systemic disease(s).
• Any significant osteoarthritis symptoms in other joints apart from the target knee which may require pharmacological treatment during the study.
• History of allergy or hypersensitivity to hyaluronic acid.
• Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.

Sponsors & Collaborators

• Goztepe Training and Research Hospital: lead

Study Sites (1)

İstanbul Medeniyet University

Istanbul, Kadıköy, 34732, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: March 4, 2019
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

TU (1)