Evaluation of Clinical Outcomes of Scaffold Treatment of Partial Meniscal Injuries of the Knee
NCT ID: NCT06475963
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2021-03-17
2025-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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patients
Patients will be recruited from all subjects treated surgically with scaffolds for partial meniscal defects from January 01, 2009 to December 31, 2019
surveys
telephone survey
Interventions
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surveys
telephone survey
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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References
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Houck DA, Kraeutler MJ, Belk JW, McCarty EC, Bravman JT. Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2018 Aug;26(8):2259-2269. doi: 10.1007/s00167-018-4838-1. Epub 2018 Jan 16.
Condello V, Dei Giudici L, Perdisa F, Screpis DU, Guerriero M, Filardo G, Zorzi C. Polyurethane scaffold implants for partial meniscus lesions: delayed intervention leads to an inferior outcome. Knee Surg Sports Traumatol Arthrosc. 2021 Jan;29(1):109-116. doi: 10.1007/s00167-019-05760-4. Epub 2019 Oct 25.
Filardo G, Kon E, Perdisa F, Sessa A, Di Martino A, Busacca M, Zaffagnini S, Marcacci M. Polyurethane-based cell-free scaffold for the treatment of painful partial meniscus loss. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):459-467. doi: 10.1007/s00167-016-4219-6. Epub 2016 Jul 9.
Grassi A, Zaffagnini S, Marcheggiani Muccioli GM, Benzi A, Marcacci M. Clinical outcomes and complications of a collagen meniscus implant: a systematic review. Int Orthop. 2014 Sep;38(9):1945-53. doi: 10.1007/s00264-014-2408-9. Epub 2014 Jun 20.
Zaffagnini S, Giordano G, Vascellari A, Bruni D, Neri MP, Iacono F, Kon E, Presti ML, Marcacci M. Arthroscopic collagen meniscus implant results at 6 to 8 years follow up. Knee Surg Sports Traumatol Arthrosc. 2007 Feb;15(2):175-83. doi: 10.1007/s00167-006-0144-4. Epub 2006 Jul 15.
Zaffagnini S, Marcheggiani Muccioli GM, Bulgheroni P, Bulgheroni E, Grassi A, Bonanzinga T, Kon E, Filardo G, Busacca M, Marcacci M. Arthroscopic collagen meniscus implantation for partial lateral meniscal defects: a 2-year minimum follow-up study. Am J Sports Med. 2012 Oct;40(10):2281-8. doi: 10.1177/0363546512456835. Epub 2012 Aug 20.
Other Identifiers
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STAR-ACT
Identifier Type: -
Identifier Source: org_study_id