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

NCT ID: NCT06433492

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-30
• Study Completion Date: 2022-12-21

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and \< 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly.

Group Type: EXPERIMENTAL

Intra-articular injection

Intervention Type: DEVICE

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

Interventions

Intra-articular injection

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 38 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biovico Sp. z o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rehasport

Poznan, , Poland

Countries

Poland

Other Identifiers

2.0 06.10.2020

Identifier Type: -

Identifier Source: org_study_id