Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: Orthopure
Reconstruction of the anterior cruciate ligament of the knee in the patient.
|
Outcome Measures
Primary Outcome Measures
- International Knee Documentation Committee [At baseline (day 0)]
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)
- International Knee Documentation Committee [After 2 months]
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)
- International Knee Documentation Committee [After 6 months]
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)
- International Knee Documentation Committee [After 24 months]
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)
- Lysholm Knee Score [At baseline (day 0)]
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).
- Lysholm Knee Score [After 2 months]
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).
- Lysholm Knee Score [After 6 months]
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).
- Lysholm Knee Score [After 24 months]
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).
- Visual Analogue Scale [At baseline (day 0)]
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.
- Visual Analogue Scale [After 2 months]
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.
- Visual Analogue Scale [After 6 months]
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.
- Visual Analogue Scale [After 24 months]
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.
- Tegner Score [At baseline (day 0)]
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
- Tegner Score [After 2 months]
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
- Tegner Score [After 6 months]
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
- Tegner Score [After 24 months]
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
- continuity of the graft [After 24 months]
assess the continuity of the graft with magnetic resonance imaging
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Istituto Ortopedico Rizzoli | Bologna | Italy | 40136 |
Sponsors and Collaborators
- Istituto Ortopedico Rizzoli
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACL-PURE