Status:
COMPLETED
Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
ACL
ACL Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06091488
Start Date
April 12 2022
End Date
August 25 2025
Last Update
September 12 2025
Active Locations (1)
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1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136