This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
36
intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery
intra-articular injection of saline after arthroscopic surgery
Kaplan Medical Center
Rehovot, Israel
RECRUITINGEfficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level
Time frame: The questionnaires will filled for 6 months after surgery
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
The subjects will answer three questionnaires for grading of their symptoms and overall functional performance
Time frame: The questionnaires will filled for 6 months after surgery.
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
Radiograph of the terget knee will be obtained.
Time frame: Change from baseline at 6 months after surgery.
Incidence of treatment-emergent adverse events.
Self reported adverse events
Time frame: self-reported adverse events will be evaluated for 6 months follow-up.
The efficacy of RegenoGel-OSP on subject's activity and quality of life.
The subjects will answer four questionnaires for grading of their symptoms, pain level and overall functional performance.
Time frame: The questionnaires will be filled for 6 months follow-up after surgery.
Incidence, relatedness and severity of treatment-emergent adverse events.
physical examination of the study knee by the investigator.
Time frame: Physical examination will be evaluated for 6 months follow-up
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