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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Patients will be recruited from all subjects treated surgically with scaffolds for partial meniscal defects from January 01, 2009 to December 31, 2019 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surveys | Other | telephone survey |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function. According to this questionnaire, a score between 0 and 100 can be obtained, where a high score is associated with a high level of function and minor pain symptoms. A score of 100 is in fact interpreted as a condition in which there are neither limitations in conducting activities of daily living nor symptoms. | baseline (post surgery) |
| Visual Analogue Scale pain | It is a one-dimensional quantitative 11-point numeric pain rating scale; the scale requires the patient to select the number that best describes the intensity of his or her pain, from 0 to 10, at that specific time. 0 means no pain and 10 indicates the worst possible pain. | baseline (post surgery) |
| EuroQoL (quality of life) Current Health Assessment | Valuable tool for measuring the quality of life of a patient. | baseline (post surgery) |
| EuroQoL Visual Analogue Scale (EQ-VAS) | This is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). | baseline (post surgery) |
| Tegner Score | It allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders. In the study, the Tegner Score will be compiled directly by the investigator, through an interview the patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from all subjects treated surgically with scaffolds (Actifit) for partial meniscal defects from January 01, 2009 to December 31, 2019
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29340746 | Result | 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. | |
| 31654130 | Result | 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. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| baseline (post surgery) |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | It is a pathology-specific questionnaire useful for the assessment of symptoms reported at the knee joint level in patients with osteoarthritis. | baseline (post surgery) |
| 27395355 | Result | 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. |
| 24947329 | Result | 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. |
| 16845545 | Result | 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. |
| 22915481 | Result | 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. |
| D012216 |
| Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |