Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.

Biovico Sp. z o.o.50 enrolled

Overview

The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Intra-articular injectionDEVICE

Three doses of intra-articular injection administered in weekely intervals.

Eligibility

Sex: ALLMin age: 38 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 38 and 70 years, * OA diagnosed by the American College of Rheumatology (ACR) criteria, * OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale), * Pain in the knee joint for at least 3 months, * Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee. Exclusion Criteria: * Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment, * Present joint infection, * Previous knee arthroscopy up to 1 year prior to examination, * Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.), * Total arthroplasty and osteotomy, * Ankylosis of the study joint, * Dermatitis or dermatological disease at the intended injection site, * Known hypersensitivity to the components of the preparation, * Coexistence of the degenerative changes in other limb joints (hip, foot), * Cancer, * Oral corticosteroid therapy, * Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs), * Pregnancy or breast-feeding. * History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease. * Participation in other clinical trials.

Locations (1)

Rehasport

Poznan, Poland

Outcomes

Primary Outcomes

The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.

The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine.

Time frame: 3 months

Secondary Outcomes

The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment

The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment.

Time frame: baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment

The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items.The patient assesses his condition using a scale by marking one of 5 options (scoring 0 - 4, where 0 - no complaints, 1 - mild, 2 - moderate, 3 - severe, 4 - extreme). The scores for each subscale are summed up to give a total subscale score, with higher scores indicating greater severity of symptoms.

Time frame: baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment

Functional status of knee joint according to time to perform the The Timed Up and Go Test.

The TUG test measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down.

Time frame: baseline, 1 month, 3 months and 6 months post-treatment

Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.

To perform "The Five Time Sit to Stand Test" (FTSST, 5xSTS), patient was asked to take a sitting position on a standard 45 cm high chair with arms crossed over the chest. At the command "START," the patient must stand up as quickly as possible five times and completely straighten up and sit back in the chair without supporting himself with his arms.

Data from ClinicalTrials.gov

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