Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee (NCT06475963) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee
Italy41 participantsStarted 2021-03-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee
Timeframe: baseline (post surgery)
2
Visual Analogue Scale pain
Timeframe: baseline (post surgery)
3
EuroQoL (quality of life) Current Health Assessment
Timeframe: baseline (post surgery)
4
EuroQoL Visual Analogue Scale (EQ-VAS)
Timeframe: baseline (post surgery)
5
Tegner Score
Timeframe: baseline (post surgery)
6
Knee Injury and Osteoarthritis Outcome Score (KOOS)