Clinical trial NCT06091488: Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Official title: Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL
ACL Injury
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: International Knee Documentation Committee
timeFrame: At baseline (day 0)
measure: International Knee Documentation Committee
timeFrame: After 2 months
measure: International Knee Documentation Committee
timeFrame: After 6 months
measure: International Knee Documentation Committee
timeFrame: After 24 months
measure: Lysholm Knee Score
timeFrame: At baseline (day 0)
measure: Lysholm Knee Score
timeFrame: After 2 months
measure: Lysholm Knee Score
timeFrame: After 6 months
measure: Lysholm Knee Score
timeFrame: After 24 months
measure: Visual Analogue Scale
timeFrame: At baseline (day 0)
measure: Visual Analogue Scale
timeFrame: After 2 months
measure: Visual Analogue Scale
timeFrame: After 6 months
measure: Visual Analogue Scale
timeFrame: After 24 months
measure: Tegner Score
timeFrame: At baseline (day 0)
measure: Tegner Score
timeFrame: After 2 months
measure: Tegner Score
timeFrame: After 6 months
measure: Tegner Score
timeFrame: After 24 months
measure: continuity of the graft
timeFrame: After 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.
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. doi: 10.1007/s00167-008-0498-x.
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/s00167-019-05450-1. Epub 2019 Apr 3.