Evaluating outcomes of scaffold treatment for knee meniscus injuries
Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee, an Observational Study.
This study is looking at how well scaffold treatment works for people with partial knee meniscus injuries who had surgery between 2009 and 2019.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06475963 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical outcomes of scaffold treatment for partial meniscal injuries in the knee. It involves identifying eligible patients, obtaining informed consent, and conducting telephone follow-ups to gather study-specific clinical data. The collected data will be analyzed to evaluate trends in patient outcomes over time following the implantation of the scaffold. The study focuses on patients who underwent surgery with scaffolds for meniscal defects between 2009 and 2019.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 65 with acute irreparable meniscal injuries or chronic meniscal tissue loss who have undergone scaffold treatment.
Not a fit: Patients with advanced cartilage injuries, significant knee instability, or those with contraindications to scaffold treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of scaffold treatments for improving knee function and quality of life in patients with meniscal injuries.
How similar studies have performed: While this study utilizes scaffold treatment, similar approaches have shown promise in other studies, indicating potential for beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.