NCT06091488

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

October 11, 2023

Last Update Submit

September 11, 2025

Conditions

ACLACL Injury

Outcome Measures

Primary Outcomes (17)

  • 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)

    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)

    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)

    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)

    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).

    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).

    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).

    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).

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    After 24 months

  • continuity of the graft

    assess the continuity of the graft with magnetic resonance imaging

    After 24 months

Study Arms (1)

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.

Other: Orthopure

Interventions

OrthopureOTHER

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

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (3)

  • 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.

    PMID: 23302260RESULT

  • 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.

    PMID: 18292988RESULT

  • 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.

    PMID: 30944945RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 19, 2023

Study Start

April 12, 2022

Primary Completion

December 1, 2022

Study Completion

August 25, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)