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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Lipotrisâ„¢. The product was administered as a course of three injections weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular injection | Device | Three doses of intra-articular injection administered in weekely intervals. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehasport | Poznan | 60-201 | Poland |
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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. |
| 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. | 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. | 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. | 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. | baseline, 1 month, 3 months and 6 months post-treatment |
| Maximum isometric force of flexor muscles of knee joint. | 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. | baseline, 1 month, 3 months and 6 months post-treatment |
| Maximum isometric force of extensor muscles of the knee joint. | baseline, 1 month, 3 months and 6 months post-treatment |
| Safety assesment | Number of patients with adverse events -type, duration and severity of every adverse event for each patient will be reported | baseline, 1 month, 3 months and 6 months post-treatment |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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