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

NCT06584838 | Not Yet Recruiting

• 1 other identifier: ALVSAT
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL; ACL Injury

Outcome Measures

Primary Outcomes (1)

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

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

  from 2 years after surgical procedure

Secondary Outcomes (3)

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

  from 2 years after surgical procedure

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

  from 2 years after surgical procedure

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

  from 2 years after surgical procedure

Study Arms (2)

Allograft

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

Procedure: ACL reconstruction

Autograft

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

Procedure: ACL reconstruction

Interventions

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

Allograft; Autograft

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that underwent ACL reconstruction using either allograft or autograft tendons, at least 2 years of follow-up, gender male and female, no comorbidities. Group 1 are patients aged ≥ 40 y.o. that underwent ACL reconstruction using allograft tendons. Group 2 are patients aged ≥ 40 y.o. that underwent ACL reconstruction using autograft tendons.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: September 5, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

IT (1)