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

Istituto Ortopedico Rizzoli

Status: Active, not recruiting

Conditions: ACL; ACL Injury

Treatments: Other: Orthopure

Study type: Interventional

Funder types: Other

Identifiers

NCT06091488

ACL-PURE

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental

Experimental group

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.

Treatment:

Other: Orthopure