Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Quadriceps Tendon Autograft, Tendon-Bone Versus All-Soft-Tissue for Anterior Cruciate Ligament Reconstruction: A Patient-Blinded Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04039971
• Other study ID #: 19-1445
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 31, 2029

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Whitney Hovater, BS
• Phone: 720-777-8216
• Email: whitney.hovater[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

It is well known that ACL injuries are among the most common sports and knee injuries. As a result, ACL reconstruction is at the forefront both in terms of research and development and advancements in technique. One focus of research is graft choice and the risks and benefits associated with each. There are multiple valid graft choices including bone-patellar tendon-bone, hamstring tendon, quadriceps tendon, quadriceps tendon-patellar bone, and allograft. Graft choice is often patient centered and based on both patient and surgeon considerations such as age, sex, activity level, surgeon preference and graft associated complications.

The present study seeks to compare the intraoperative, immediate perioperative, intermediate and long-term outcomes between tendon-bone and all-soft-tissue quadriceps tendon autograft in ACL reconstruction in adolescent patients. The investigators will analyze data on operative time, cost, complications, recovery of strength and range of motion, return to sports rates, patient reported outcomes, and failure rates. With this proposal the investigators hope to determine if there is a superior graft technique in this population. Both graft types are validated in the literature separately as options for ACL reconstruction in this age group. There has been no clinical research comparing the two graft types, and therefore no consensus is made among surgeons on whether to use tendon-bone or all-soft-tissue when it comes to the QT autograft. A secondary aim of this study is to obtain patient reported outcomes throughout the post-operative period to determine if the patient experience is different between the two graft types. This data may be used in guiding a surgeon's decision on which type to use with their patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Males and females

• Patients ages 12 to 19 (inclusive)

• Patients undergoing primary ACL reconstruction

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

Procedure:
• ACL Reconstruction
Surgical techniques

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Long-Term Graft Superiority	Long-term graft superiority will be evaluated by graft failure rate or ACL re-rupture.	5 years
Secondary	Patient Reported Outcomes	Patients will complete a survey at specific time points to gauge knee function throughout treatment.	Pre-operative appointment, 3 months, 6 months, 12 months, 24 months, and 5 years post-operative appointments
Secondary	Time to Return to Sports Rates	Time to return to sports will be evaluated based on physical therapy milestones related to return to sports clearance.	As recorded in post-operative physical therapy visits (approx. 6 months to 1 year)