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

Not Applicable

Active, not recruiting

• Conditions: ACL Injury; ACL
• Interventions: Other: Orthopure

• Registration Number: NCT06091488
• Lead Sponsor: Istituto Ortopedico Rizzoli

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-12
• Primary Completion: 2022-12-01
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Orthopure	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.

Primary Outcome Measures

Name	Time	Method
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).
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
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.
continuity of the graft	After 24 months	assess the continuity of the graft with magnetic resonance imaging
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)

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy