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

ACL Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06091488
• Other study ID #: ACL-PURE
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Other:
• Orthopure
Reconstruction of the anterior cruciate ligament of the knee in the patient.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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/s00167-019-0 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	continuity of the graft	assess the continuity of the graft with magnetic resonance imaging	After 24 months