Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt

Study Overview
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Brief Summary
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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

Official Title
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Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt

Conditions
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ACL, ACL Injury

Intervention / Treatment
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* Other: Orthopure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18 and 65 at the time of ACL reconstruction surgery; Patients aged 35 to 65 at the time of primary ACL reconstruction surgery; Male and female sex; First injury of the ACL with impossibility of use of autograft (patellar tendinopathy, quadriceps tendinopathy, goose leg tendinopathy) or refusal to use allograft (Bank tendon); Recurrence of ACL injury with impossibility of use of autograft (prior use/tendinopathy of the patellar, previous use/tendinopathy of the quadriceps, previous use/tendinopathy of the goose leg) or refusal to use allograft (tendon of Bank); Exclusion Criteria: Patients who do not consent to be included in the study Presence of haematological, rheumatic or haemorrhagic disease time of assessment ACL primary reconstruction in subjects under 35 Allergies and/or reactions from hypersensitivity or religious objection to the use of porcine derivation Pregnant and/or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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. | Other: Orthopure<br>* Reconstruction of the anterior cruciate ligament of the knee in the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 |