Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee
NCT Number: NCT06475963
Acronym: STAR-ACT
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Knee Osteoarthritis|Knee Injuries|Meniscus Lesion
Interventions: OTHER: surveys
Sponsor: Istituto Ortopedico Rizzoli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Observational Model: |Time Perspective: p
Start Date: 2021-03-17
Completion Date: 2024-07-31
Locations: Istituto Ortopedico Rizzoli, Bologna, 40136, Italy

Summary:
The study consists of 3 phases (Identification of includable patients, Telephone follow-up evaluation and the collection of study-specific clinical data in medical records of enrolled patients):

* Identification by trained medical personnel of subjects who meet the study's inclusion criteria.
* Once the patient's Informed Consent has been obtained, the study-specific questionnaires will be submitted by telephone.
* Study-specific clinical score data will be collected from the medical records of patients enrolled in the study. These data will be used, together with the data collected during the telephone follow-up, to evaluate the trend in outcomes over time after implantation of this scaffold.

Primary Outcome Measures: International Knee Documentation Committee, This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, where a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms., baseline (post surgery)|Visual Analogue Scale pain, It is a one-dimensional quantitative 11-point numeric pain rating scale; the scale requires the patient to select the number that best describes the intensity of his or her pain, from 0 to 10, at that specific time. 0 means no pain and 10 indicates the worst possible pain., baseline (post surgery)|EuroQoL (quality of life) Current Health Assessment, Valuable tool for measuring the quality of life of a patient., baseline (post surgery)|EuroQoL Visual Analogue Scale (EQ-VAS), This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition)., baseline (post surgery)|Tegner Score, It allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. In the study, the Tegner Score will be compiled directly by the investigator, through an interview the patient., baseline (post surgery)|Knee Injury and Osteoarthritis Outcome Score (KOOS), It is a pathology-specific questionnaire useful for the assessment of symptoms reported at the knee joint level in patients with osteoarthritis., baseline (post surgery)