Back to resultsEvaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Primary Purpose
ACL, ACL Injury
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Orthopure
Sponsored by
About this trial
This is an interventional treatment trial for ACL
Eligibility 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
Sites / Locations
- IRCCS Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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).
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).
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).
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).
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.
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.
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.
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.
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
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
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
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
continuity of the graft
assess the continuity of the graft with magnetic resonance imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT06091488
First Posted
October 11, 2023
Last Updated
October 17, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT06091488
Brief Title
Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Official Title
Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL, ACL Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Orthopure
Intervention Description
Reconstruction of the anterior cruciate ligament of the knee in the patient.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee
Description
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)
Time Frame
At baseline (day 0)
Title
International Knee Documentation Committee
Description
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)
Time Frame
After 2 months
Title
International Knee Documentation Committee
Description
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)
Time Frame
After 6 months
Title
International Knee Documentation Committee
Description
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)
Time Frame
After 24 months
Title
Lysholm Knee Score
Description
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).
Time Frame
At baseline (day 0)
Title
Lysholm Knee Score
Description
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).
Time Frame
After 2 months
Title
Lysholm Knee Score
Description
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).
Time Frame
After 6 months
Title
Lysholm Knee Score
Description
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).
Time Frame
After 24 months
Title
Visual Analogue Scale
Description
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.
Time Frame
At baseline (day 0)
Title
Visual Analogue Scale
Description
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.
Time Frame
After 2 months
Title
Visual Analogue Scale
Description
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.
Time Frame
After 6 months
Title
Visual Analogue Scale
Description
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.
Time Frame
After 24 months
Title
Tegner Score
Description
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
Time Frame
At baseline (day 0)
Title
Tegner Score
Description
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
Time Frame
After 2 months
Title
Tegner Score
Description
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
Time Frame
After 6 months
Title
Tegner Score
Description
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
Time Frame
After 24 months
Title
continuity of the graft
Description
assess the continuity of the graft with magnetic resonance imaging
Time Frame
After 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23302260
Citation
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.
Results Reference
result
PubMed Identifier
18292988
Citation
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.
Results Reference
result
PubMed Identifier
30944945
Citation
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.
Results Reference
result
Learn more about this trial
Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
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