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The purpose of this study is to evaluate subjective and objective clinical outcomes and imaging data of subjects undergoing reconstruction or revision of LCA reconstruction using OrthoPure XT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients with anterior cruciate ligament injury, in which the patient's own autologous tendons cannot be used, will be treated with the ligamentous reconstruction device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthopure | Other | Reconstruction of the anterior cruciate ligament of the knee in the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee | The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30) | At baseline (day 0) |
| International Knee Documentation Committee | The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30) | After 2 months |
| International Knee Documentation Committee | The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30) | After 6 months |
| International Knee Documentation Committee | The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30) | After 24 months |
| Lysholm Knee Score | The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (<64). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23302260 | Result | Collins JE, Katz JN, Donnell-Fink LA, Martin SD, Losina E. Cumulative incidence of ACL reconstruction after ACL injury in adults: role of age, sex, and race. Am J Sports Med. 2013 Mar;41(3):544-9. doi: 10.1177/0363546512472042. Epub 2013 Jan 9. | |
| 18292988 | Result | Kessler MA, Behrend H, Henz S, Stutz G, Rukavina A, Kuster MS. Function, osteoarthritis and activity after ACL-rupture: 11 years follow-up results of conservative versus reconstructive treatment. Knee Surg Sports Traumatol Arthrosc. 2008 May;16(5):442-8. doi: 10.1007/s00167-008-0498-x. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| At baseline (day 0) |
| Lysholm Knee Score | The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (<64). | After 2 months |
| Lysholm Knee Score | The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (<64). | After 6 months |
| Lysholm Knee Score | The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (<64). | After 24 months |
| Visual Analogue Scale | is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain. | At baseline (day 0) |
| Visual Analogue Scale | is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain. | After 2 months |
| Visual Analogue Scale | is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain. | After 6 months |
| Visual Analogue Scale | is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain. | After 24 months |
| Tegner Score | allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports | At baseline (day 0) |
| Tegner Score | allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports | After 2 months |
| Tegner Score | allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports | After 6 months |
| Tegner Score | allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports | After 24 months |
| continuity of the graft | assess the continuity of the graft with magnetic resonance imaging | After 24 months |
| 30944945 | Result | Costa GG, Grassi A, Perelli S, Agro G, Bozzi F, Lo Presti M, Zaffagnini S. Age over 50 years is not a contraindication for anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2019 Nov;27(11):3679-3691. doi: 10.1007/s00167-019-05450-1. Epub 2019 Apr 3. |