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

Not yet recruiting

• Conditions: ACL; ACL Injury
• Interventions: Procedure: ACL reconstruction

• Registration Number: NCT06584838
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-29
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Study Start: 2024-12
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allograft	ACL reconstruction	Patients aged ≥ 40 y.o. that underwent ACL reconstruction using allograft tendons
Autograft	ACL reconstruction	Patients aged ≥ 40 y.o. that underwent ACL reconstruction using autograft tendons

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction	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)

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Milano, Italy