NCT04039971

Brief Summary

In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Aug 2020Aug 2029

First Submitted

Initial submission to the registry

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

9.1 years

First QC Date

July 26, 2019

Last Update Submit

March 27, 2025

Conditions

Anterior Cruciate Ligament InjuriesAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament Tear

Keywords

ACLACL TearACL InjuryACL RuptureAnterior Cruciate Ligament TearAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament InjuriesAnterior Cruciate LigamentACL RepairACL ReconstructionACL SurgeryAnterior Cruciate Ligament RepairAnterior Cruciate Ligament ReconstructionAnterior Cruciate Ligament Surgery

Outcome Measures

Primary Outcomes (2)

  • Short-Term Graft Superiority

    Graft superiority will be evaluated by the time to return to sports and the length of return to sports.

    1 to 2 years

  • Long-Term Graft Superiority

    Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.

    5 years

Secondary Outcomes (2)

  • Patient Reported Outcomes

    Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments

  • Time to Return to Sports Rates

    As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)

Study Arms (2)

Tendon-Bone Graft

ACTIVE COMPARATOR

Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction.

Procedure: ACL Reconstruction

All-Soft-Tissue Graft

ACTIVE COMPARATOR

Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction.

Procedure: ACL Reconstruction

Interventions

ACL ReconstructionPROCEDURE

Surgical techniques

All-Soft-Tissue GraftTendon-Bone Graft

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and females
  • Patients ages 12 to 19 (inclusive)
  • Patients undergoing primary ACL reconstruction

You may not qualify if:

  • Patients with an underlying neuromuscular diagnosis or neurological injury
  • Patients with lower extremity fractures, dislocations, or multi-ligamentous injuries, which required surgery, concurrent with or occurring two years or less prior to primary ACL injury.
  • Patients with an underlying systemic or musculoskeletal diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (15)

  • Kaeding CC, Pedroza AD, Reinke EK, Huston LJ, Hewett TE, Flanigan DC; MOON Knee Group; Spindler KP. Change in Anterior Cruciate Ligament Graft Choice and Outcomes Over Time. Arthroscopy. 2017 Nov;33(11):2007-2014. doi: 10.1016/j.arthro.2017.06.019. Epub 2017 Aug 26.

    PMID: 28847572BACKGROUND

  • Fineberg MS, Zarins B, Sherman OH. Practical considerations in anterior cruciate ligament replacement surgery. Arthroscopy. 2000 Oct;16(7):715-24. doi: 10.1053/jars.2000.8951.

    PMID: 11027755BACKGROUND

  • Middleton KK, Hamilton T, Irrgang JJ, Karlsson J, Harner CD, Fu FH. Anatomic anterior cruciate ligament (ACL) reconstruction: a global perspective. Part 1. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1467-82. doi: 10.1007/s00167-014-2846-3. Epub 2014 Feb 5.

    PMID: 24497054BACKGROUND

  • DeAngelis JP, Fulkerson JP. Quadriceps tendon--a reliable alternative for reconstruction of the anterior cruciate ligament. Clin Sports Med. 2007 Oct;26(4):587-96. doi: 10.1016/j.csm.2007.06.005.

    PMID: 17920954BACKGROUND

  • Crall TS, Gilmer BB. Anatomic All-Inside Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Autograft. Arthrosc Tech. 2015 Dec 23;4(6):e841-5. doi: 10.1016/j.eats.2015.08.004. eCollection 2015 Dec.

    PMID: 27284521BACKGROUND

  • Lee S, Seong SC, Jo CH, Han HS, An JH, Lee MC. Anterior cruciate ligament reconstruction with use of autologous quadriceps tendon graft. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:116-26. doi: 10.2106/JBJS.G.00632. No abstract available.

    PMID: 17908877BACKGROUND

  • Ferrer GA, Miller RM, Murawski CD, Tashman S, Irrgang JJ, Musahl V, Fu FH, Debski RE. Quantitative analysis of the patella following the harvest of a quadriceps tendon autograft with a bone block. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2899-2905. doi: 10.1007/s00167-015-3550-7. Epub 2015 Mar 7.

    PMID: 25749653BACKGROUND

  • Fink C, Herbort M, Abermann E, Hoser C. Minimally invasive harvest of a quadriceps tendon graft with or without a bone block. Arthrosc Tech. 2014 Aug 11;3(4):e509-13. doi: 10.1016/j.eats.2014.06.003. eCollection 2014 Aug.

    PMID: 25264512BACKGROUND

  • Sprowls GR, Robin BN. The Quad Link Technique for an All-Soft-Tissue Quadriceps Graft in Minimally Invasive, All-Inside Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2018 Jul 16;7(8):e845-e852. doi: 10.1016/j.eats.2018.04.004. eCollection 2018 Aug.

    PMID: 30167363BACKGROUND

  • Schulz AP, Lange V, Gille J, Voigt C, Frohlich S, Stuhr M, Jurgens C. Anterior cruciate ligament reconstruction using bone plug-free quadriceps tendon autograft: intermediate-term clinical outcome after 24-36 months. Open Access J Sports Med. 2013 Nov 19;4:243-9. doi: 10.2147/OAJSM.S49223. eCollection 2013.

    PMID: 24379730BACKGROUND

  • Gorschewsky O, Klakow A, Putz A, Mahn H, Neumann W. Clinical comparison of the autologous quadriceps tendon (BQT) and the autologous patella tendon (BPTB) for the reconstruction of the anterior cruciate ligament. Knee Surg Sports Traumatol Arthrosc. 2007 Nov;15(11):1284-92. doi: 10.1007/s00167-007-0371-3. Epub 2007 Aug 25.

    PMID: 17721778BACKGROUND

  • Han HS, Seong SC, Lee S, Lee MC. Anterior cruciate ligament reconstruction : quadriceps versus patellar autograft. Clin Orthop Relat Res. 2008 Jan;466(1):198-204. doi: 10.1007/s11999-007-0015-4. Epub 2008 Jan 3.

    PMID: 18196393BACKGROUND

  • Kim SJ, Lee SK, Choi CH, Kim SH, Kim SH, Jung M. Graft selection in anterior cruciate ligament reconstruction for smoking patients. Am J Sports Med. 2014 Jan;42(1):166-72. doi: 10.1177/0363546513505191. Epub 2013 Oct 10.

    PMID: 24114749BACKGROUND

  • Kim SJ, Kumar P, Oh KS. Anterior cruciate ligament reconstruction: autogenous quadriceps tendon-bone compared with bone-patellar tendon-bone grafts at 2-year follow-up. Arthroscopy. 2009 Feb;25(2):137-44. doi: 10.1016/j.arthro.2008.09.014. Epub 2008 Nov 20.

    PMID: 19171272BACKGROUND

  • Streich NA, Barie A, Gotterbarm T, Keil M, Schmitt H. Transphyseal reconstruction of the anterior cruciate ligament in prepubescent athletes. Knee Surg Sports Traumatol Arthrosc. 2010 Nov;18(11):1481-6. doi: 10.1007/s00167-010-1057-9. Epub 2010 Feb 4.

    PMID: 20130837BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Stephanie Mayer, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 31, 2019

Study Start

August 1, 2020

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with individuals or organizations outside of the research team.

Locations

US(1)