Clinical trial NCT06433492: Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
Official title: Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Biovico Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2024-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 38
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
timeFrame: 3 months
Secondary outcomes:
measure: The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
timeFrame: baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
measure: The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
timeFrame: baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
measure: Functional status of knee joint according to time to perform the The Timed Up and Go Test.
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
measure: Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
measure: Functional status of knee joint according to time to perform the to 10 Meter Walk Test.
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
measure: Maximum isometric force of flexor muscles of knee joint.
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
measure: Maximum isometric force of extensor muscles of the knee joint.
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
measure: Safety assesment
timeFrame: baseline, 1 month, 3 months and 6 months post-treatment
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Rehasport
Study officials:
References: