Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversità Vita-Salute San Raffaele
About this trial
The aim of this study is to investigate the differences in graft failure between patients that underwent ACL reconstruction using allograft tendons and patients that underwent ACL reconstruction using autograft tendons in patients older than 40 y.o. and after at least 2 years of follow-up. The hypothesis of the study is that there will be a difference in graft failure and patient reported functional outcomes between allograft and autograft ACL reconstruction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Male and female patients of fertile age can be recruited
Patients aged 40 years old and above, and 2 years minimum of follow-up
Patients that underwent primary ACL reconstruction with allograft an autograft tendons
Disqualifiers
Multiligamentous lesion
Meniscal tear leading to subtotal or total meniscectomy or meniscal graft
Indication for major cartilage restoration or resurfacing
Ipsilateral knee fractures
Trial population
Patients that underwent ACL reconstruction using either allograft or autograft tendons, at least 2 years of follow-up, gender male and female, no comorbidities. Group 1 are patients aged ≥ 40 y.o. that underwent ACL reconstruction using allograft tendons. Group 2 are patients aged ≥ 40 y.o. that underwent ACL reconstruction using autograft tendons.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
ACL reconstruction
Procedure/SurgeryPatients that underwent ACL reconstruction using either allograft or autograft tendons, at least 2 years of follow-up, gender male and female, no comorbidities
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Allograft1 intervention
Group B: Autograft1 intervention
Trial outcomes
Primary outcomes
1
To compare the difference in graft failure between allograft vs autograft ACL reconstruction
Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction
Time frame
from 2 years after surgical procedureSecondary outcomes
1
To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction
Clinical evaluation collecting Tegner Lysholm Score (max, 100 - min. 0) (100 = no disability; 0= maximum siability)
Time frame
from 2 years after surgical procedure2
To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction
Clinical evaluation collecting the Visual Analogue Scale for Pain (VAS) (min.0 - max. 10) (0= no pain; 100 maximum pain)
Time frame
from 2 years after surgical procedure3
To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction
Clinical evaluation collecting the International Knee Document Comitee Score (IKDC) (min. 0 - max. 100) (0= lowest level of function; 100= highest level of fuction)
Time frame
from 2 years after surgical procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Università Vita-Salute San Raffaele
Lead sponsor
IRCCS Ospedale San Raffaele
Sponsor institution
Source ClinicalTrials.gov
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