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Completed

NCT Number: NCT06091488

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

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

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Key information

Conditions

ACL ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthopure

Other

Reconstruction of the anterior cruciate ligament of the knee in the patient.

Primary outcomes

  1. International Knee Documentation Committee

    Time frame: 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)

  2. International Knee Documentation Committee

    Time frame: 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)

  3. International Knee Documentation Committee

    Time frame: 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)

  4. International Knee Documentation Committee

    Time frame: 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)

  5. Lysholm Knee Score

    Time frame: 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).

  6. Lysholm Knee Score

    Time frame: 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).

  7. Lysholm Knee Score

    Time frame: 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).

  8. Lysholm Knee Score

    Time frame: 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).

  9. Visual Analogue Scale

    Time frame: 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.

  10. Visual Analogue Scale

    Time frame: 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.

  11. Visual Analogue Scale

    Time frame: 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.

  12. Visual Analogue Scale

    Time frame: 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.

  13. Tegner Score

    Time frame: 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

  14. Tegner Score

    Time frame: 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

  15. Tegner Score

    Time frame: 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

  16. Tegner Score

    Time frame: 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

  17. continuity of the graft

    Time frame: After 24 months

    assess the continuity of the graft with magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2025
First posted
Oct 19, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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