Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06584838

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ACL ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACL reconstruction

Procedure

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

Primary outcomes

  1. To compare the difference in graft failure between allograft vs autograft ACL reconstruction

    Time frame: from 2 years after surgical procedure

    Clinical evaluation measuring the percentage in graft failure between allograft and autograft ACL reconstruction

Secondary outcomes

  1. To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction

    Time frame: from 2 years after surgical procedure

    Clinical evaluation collecting Tegner Lysholm Score (max, 100 - min. 0) (100 = no disability; 0= maximum siability)

  2. To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction

    Time frame: from 2 years after surgical procedure

    Clinical evaluation collecting the Visual Analogue Scale for Pain (VAS) (min.0 - max. 10) (0= no pain; 100 maximum pain)

  3. To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction

    Time frame: from 2 years after surgical procedure

    Clinical evaluation collecting the International Knee Document Comitee Score (IKDC) (min. 0 - max. 100) (0= lowest level of function; 100= highest level of fuction)

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.