Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft

Primary ACL Reconstruction in Patient Over 40 Years: Allograft Versus Autograft, a Prospective Matched Paired Comparison

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06584838

Enrollment

Registered

2024-09-05

Start date

2024-12-31

Completion date

2025-02-28

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL, ACL Injury

Brief summary

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.

Interventions

PROCEDUREACL reconstruction

Patients that underwent ACL reconstruction using either allograft or autograft tendons, at least 2 years of follow-up, gender male and female, no comorbidities

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Multiligamentous lesion * Meniscal tear leading to subtotal or total meniscectomy or meniscal graft * Indication for major cartilage restoration or resurfacing * Ipsilateral knee fractures * History of ligament injury * Concomitant extracapsular procedures * Ipsilateral or contralateral knee surgeries

Design outcomes

Primary

Measure	Time frame	Description
To compare the difference in graft failure between allograft vs autograft ACL reconstruction	from 2 years after surgical procedure	Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction

Secondary

Measure	Time frame	Description
To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction	from 2 years after surgical procedure	Clinical evaluation collecting Tegner Lysholm Score (max, 100 - min. 0) (100 = no disability; 0= maximum siability)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026