Menu
Not yet recruiting NCT06584838

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

— Observational ACL ACL Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACL reconstruction.
Who it may be relevant to
Registry conditions: ACL, ACL Injury. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure 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

Primary outcome measures

  • To compare the difference in graft failure between allograft vs autograft ACL reconstruction [Time frame: from 2 years after surgical procedure]
Secondary outcome measures (3)
  • To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction [Time frame: from 2 years after surgical procedure]
  • To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction [Time frame: from 2 years after surgical procedure]
  • To assess the difference in patient reported outcome between allograft vs autograft ACL reconstruction [Time frame: from 2 years after surgical procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan

Publications

  • 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. PMID 16009990
  • 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. PMID 18657740
  • 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. PMID 12368781
  • 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. PMID 27018510
  • 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. PMID 27385681
  • 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. PMID 27327925
  • 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. PMID 26427630
  • 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. PMID 25899429

Identifiers

NCT: NCT06584838 · ALVSAT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗