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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for patients with specific knee injuries, particularly those involving the meniscus, which is a cushioning tissue in the knee. The goal is to evaluate how well a special scaffold treatment helps improve symptoms and recovery from partial meniscal injuries. The study will involve identifying eligible patients, collecting information through phone interviews, and reviewing medical records to track progress over time after the treatment.

To be eligible for this trial, participants should be between 18 and 65 years old and have a significant meniscal injury that requires surgical treatment. They should have a healthy knee on the opposite side and no severe cartilage damage or other complicating health issues. During the trial, participants can expect to answer questions about their health and recovery after receiving the scaffold treatment. It's important to note that the trial is currently recruiting participants, and those interested should discuss with their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• 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.