ACLNCT06091488

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

A study testing Orthopure in people with ACL and ACL Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: ACL, ACL Injury
What is being tested?: Orthopure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteItaly
Study dates: 12 Apr 2022to 25 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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);

Who cannot join

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 locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136

Other trials in Italy

About this study

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

Conditions: ACL, ACL Injury
Being tested: Orthopure
Medical subject headings: Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06091488
Study group	Role	What they receive
Experimental	Experimental	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. Receives: Other: Orthopure

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: At baseline (day 0)
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)
Measured: After 2 months
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)
Measured: After 6 months
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)
Measured: After 24 months
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).
Measured: At baseline (day 0)
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).
Measured: After 2 months
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).
Measured: After 6 months
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).
Measured: After 24 months
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.
Measured: At baseline (day 0)
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.
Measured: After 2 months
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.
Measured: After 6 months
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.
Measured: After 24 months
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
Measured: At baseline (day 0)
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
Measured: After 2 months
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
Measured: After 6 months
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
Measured: After 24 months
continuity of the graft
assess the continuity of the graft with magnetic resonance imaging
Measured: After 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 202225 Aug 2025

First posted19 Oct 2023
Study start12 Apr 2022
Primary completion1 Dec 2022
Study completion25 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ACLStudies of the same condition, open and under way.
More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06091488
Sponsor's protocol ID: ACL-PURE
Status last verified: Sep 2025
First submitted: 11 Oct 2023
Last updated: 12 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23302260
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.
PubMed 18292988
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.
PubMed 30944945

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries

All ACL trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
ClinicalTrials.gov ID: NCT06091488
Acronym / sponsor ID: ACL-PURE
Conditions: ACL, ACL Injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Istituto Ortopedico RizzoliUniversity, hospital or other
Study start: 12 Apr 2022 (actual)
Primary completion: 1 Dec 2022 (actual)
Study completion: 25 Aug 2025 (actual)
First posted: 19 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Other: OrthopurePatients with anterior cruciate ligament injury, in which the patient's own autologous tendons cannot be used, will be treated with the ligamentous reconstruction device.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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);

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OrthopureReconstruction of the anterior cruciate ligament of the knee in the patient.	Other	Experimental

Primary outcome

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)
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)
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)
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)
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).
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).
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).
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).
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.
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.
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.
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.
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
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
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
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
continuity of the graft
Time frame: After 24 months
assess the continuity of the graft with magnetic resonance imaging

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
Results publication: PubMed 23302260Collins 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 publication: PubMed 18292988Kessler 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 publication: PubMed 30944945Costa 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.
Individual participant dataSharing planned: No

Related trials for ACL

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Orthopure in people with ACL and ACL Injury, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Knee Documentation Committee (time frame: At baseline (day 0)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091488, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.