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

NCT ID: NCT06584838

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-02-28

Brief Summary

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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

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Conditions

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ACL ACL Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Allograft

Patients aged ≥ 40 y.o. that underwent ACL reconstruction using allograft tendons

ACL reconstruction

Intervention Type 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

Autograft

Patients aged ≥ 40 y.o. that underwent ACL reconstruction using autograft tendons

ACL reconstruction

Intervention Type 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

Interventions

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ACL 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Professor Giacomo Placella

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Site Status

Countries

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Italy

Facility Contacts

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Francesco Pezone

Role: primary

+39 3339922420

Daniele Tradati, MD

Role: backup

References

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Barrett G, Stokes D, White M. Anterior cruciate ligament reconstruction in patients older than 40 years: allograft versus autograft patellar tendon. Am J Sports Med. 2005 Oct;33(10):1505-12. doi: 10.1177/0363546504274202. Epub 2005 Jul 11.

Reference Type BACKGROUND
PMID: 16009990 (View on PubMed)

Seng K, Appleby D, Lubowitz JH. Operative versus nonoperative treatment of anterior cruciate ligament rupture in patients aged 40 years or older: an expected-value decision analysis. Arthroscopy. 2008 Aug;24(8):914-20. doi: 10.1016/j.arthro.2008.01.021. Epub 2008 Apr 18.

Reference Type BACKGROUND
PMID: 18657740 (View on PubMed)

Kuechle DK, Pearson SE, Beach WR, Freeman EL, Pawlowski DF, Whipple TL, Caspari Dagger RB, Meyers JF. Allograft anterior cruciate ligament reconstruction in patients over 40 years of age. Arthroscopy. 2002 Oct;18(8):845-53. doi: 10.1053/jars.2002.36140.

Reference Type BACKGROUND
PMID: 12368781 (View on PubMed)

Budny J, Fox J, Rauh M, Fineberg M. Emerging Trends in Anterior Cruciate Ligament Reconstruction. J Knee Surg. 2017 Jan;30(1):63-69. doi: 10.1055/s-0036-1579788. Epub 2016 Mar 28.

Reference Type BACKGROUND
PMID: 27018510 (View on PubMed)

Tibor L, Chan PH, Funahashi TT, Wyatt R, Maletis GB, Inacio MC. Surgical Technique Trends in Primary ACL Reconstruction from 2007 to 2014. J Bone Joint Surg Am. 2016 Jul 6;98(13):1079-89. doi: 10.2106/JBJS.15.00881.

Reference Type BACKGROUND
PMID: 27385681 (View on PubMed)

Salminen M, Kraeutler MJ, Freedman KB, Tucker BS, Salvo JP, Ciccotti MG, Cohen SB. Choosing a Graft for Anterior Cruciate Ligament Reconstruction: Surgeon Influence Reigns Supreme. Am J Orthop (Belle Mead NJ). 2016 May-Jun;45(4):E192-7.

Reference Type BACKGROUND
PMID: 27327925 (View on PubMed)

Joyce CD, Randall KL, Mariscalco MW, Magnussen RA, Flanigan DC. Bone-Patellar Tendon-Bone Versus Soft-Tissue Allograft for Anterior Cruciate Ligament Reconstruction: A Systematic Review. Arthroscopy. 2016 Feb;32(2):394-402. doi: 10.1016/j.arthro.2015.08.003. Epub 2015 Sep 28.

Reference Type BACKGROUND
PMID: 26427630 (View on PubMed)

Kaeding CC, Pedroza AD, Reinke EK, Huston LJ; MOON Consortium; Spindler KP. Risk Factors and Predictors of Subsequent ACL Injury in Either Knee After ACL Reconstruction: Prospective Analysis of 2488 Primary ACL Reconstructions From the MOON Cohort. Am J Sports Med. 2015 Jul;43(7):1583-90. doi: 10.1177/0363546515578836. Epub 2015 Apr 21.

Reference Type BACKGROUND
PMID: 25899429 (View on PubMed)

Other Identifiers

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ALVSAT

Identifier Type: -

Identifier Source: org_study_id

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