Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee

Recruiting

• Conditions: Knee Osteoarthritis; Meniscus Lesion; Knee Injuries

• Registration Number: NCT06475963
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Acute irreparable meniscal injuries requiring partial meniscectomy or chronic meniscal tissue loss (traumatic or degenerative) greater than 25%; Intact anterior and posterior meniscal horn respectively;
• Peripheral meniscal rim (1 mm or more) along the entire circumference of the involved meniscus;
• Knee stability or anterior cruciate ligament injury stabilized at the time of surgery;
• Male or female patients between the ages of 18 and 65 years;
• Healthy contralateral knee;
• Normal axial alignment of the knee (mechanical tibio-femoral angle < 3°)
• Patients treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019

Exclusion Criteria

• Patients no longer available;
• Concomitant posterior cruciate ligament (PCL) injury;
• Advanced cartilage injuries according to Outerbridge classification (IV);
• Incorrect axial alignment of the lower limb;
• Documented allergy to polyurethane;
• Local or systemic infection;
• History of previous anaphylactoid reaction;
• Systemic administration of corticosteroids or immunosuppressive drugs within 30 days prior to surgery;
• Evidence of osteonecrosis in the involved knee;
• Positive history of rheumatoid arthritis, inflammatory arthritis and autoimmune diseases;
• Neurological disorders or conditions that may affect the rehabilitation protocol;
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EuroQoL Visual Analogue Scale (EQ-VAS)	baseline (post surgery)	This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Tegner Score	baseline (post surgery)	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.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	baseline (post surgery)	It is a pathology-specific questionnaire useful for the assessment of symptoms reported at the knee joint level in patients with osteoarthritis.
International Knee Documentation Committee	baseline (post surgery)	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.
Visual Analogue Scale pain	baseline (post surgery)	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.
EuroQoL (quality of life) Current Health Assessment	baseline (post surgery)	Valuable tool for measuring the quality of life of a patient.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy