## Protocol Section
### Identification Module
**NCT ID:** NCT06433492

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** 2.0 06.10.2020
#### Organization
**Class:** INDUSTRY
**Full Name:** Biovico Sp. z o.o.
### Status Module
#### Completion Date
**Date:** 2022-12-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-21

**Type:** ACTUAL

#### Start Date
**Date:** 2020-12-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Biovico Sp. z o.o.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Osteoarthritis, Knee

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Intra-articular injection

**Label:** Study group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study group

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

**Name:** Intra-articular injection

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

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

**Time Frame:** 3 months

#### Secondary Outcomes

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

**Measure:** 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

**Description:** 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.

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

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

**Description:** 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.

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

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

**Description:** 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.

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

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

**Description:** The 10 Meter Walk Test (10MWT) is a clinical assessment tool used to evaluate a patient's walking speed and mobility. The test involves measuring the time it takes for a patient to walk 10 meters (33 feet) at normal, self-selected pace.

**Measure:** Functional status of knee joint according to time to perform the to 10 Meter Walk Test.

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

**Description:** Maximal voluntary isometric contraction (MVIC) of extensor/flexor muscles of knee joint measurement was performed with Forcemeter FB 500 (AXIS, Gdansk, Poland). To measure the maximum isometric force of the knee joint extensors/flexors, a person sits on a bench with the belt around waist and legs placed freely beyond the table. The measuring belt is placed parallel to the floor just above the ankle joint with knee flexed to 90 degrees. The length of the measuring belt is specified 160 cm for extensors and 60 cm for flexors. The procedure starts with the measuring belt pretension, then the patient is asked to extend/flex the knee as hard as patient can and hold it for 6 s.

**Measure:** Maximum isometric force of flexor muscles of knee joint.

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

**Measure:** Maximum isometric force of extensor muscles of the knee joint.

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

**Description:** Number of patients with adverse events -type, duration and severity of every adverse event for each patient will be reported

**Measure:** Safety assesment

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

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 38 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Poznań

**Country:** Poland

**Facility:** Rehasport

**Zip:** 60-201

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthrosis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Osteoarthritis, Knee

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T404

- Name: Lecithin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
