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

NCT06433492 | Completed DMC

• 1 other identifier: 2.0 06.10.2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

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

  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

  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.

  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.

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

• Functional status of knee joint according to time to perform the to 10 Meter Walk Test.

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

Study Arms (1)

Study group

EXPERIMENTAL

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.

Device: Intra-articular injection

Interventions

Intra-articular injection DEVICE

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

Study group

Eligibility Criteria

• Age: 38 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biovico Sp. z o.o.: lead

Study Sites (1)

Rehasport

Poznan, 60-201, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: December 30, 2020
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

PL (1)