Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 41 people enrolled
- Started
- 17 Mar 2021
- Ended
- 31 Jul 2025
- Type of study
- Observational
- Treatments tested
- surveys
- Record updated
- 24 December 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Concomitant posterior cruciate ligament (PCL) injury
- History of previous anaphylactoid reaction
- Systemic administration of corticosteroids or immunosuppressive drugs within 30 days prior to surgery
- Documented allergy to polyurethane
- Local or systemic infection
- Positive history of rheumatoid arthritis, inflammatory arthritis and autoimmune diseases
- Neurological disorders or conditions that may affect the rehabilitation protocol
- Patients no longer available
- Advanced cartilage injuries according to Outerbridge classification (IV)
- Incorrect axial alignment of the lower limb
- Evidence of osteonecrosis in the involved knee
- Pregnancy
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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):
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* 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.
The group in the trial
- patients
Patients will be recruited from all subjects treated surgically with scaffolds for partial meniscal defects from January 01, 2009 to December 31, 2019
Treatment: surveys
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee, an Observational Study.
- Record updated
- 24 December 2025