Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital Colorado | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tendon-Bone Graft | Active Comparator | Participants receive the Quadriceps Tendon Tendon-Bone Graft technique during ACL reconstruction. |
|
| All-Soft-Tissue Graft | Active Comparator | Participants receive the Quadriceps Tendon All-Soft-Tissue Graft technique during ACL reconstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL Reconstruction | Procedure | Surgical techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to Return to Sports Rates |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Mayer, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28847572 | Background | 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. | |
| 11027755 | Background | 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. |
Not provided
Not provided
IPD will not be shared with individuals or organizations outside of the research team.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
| 24497054 | Background | 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. |
| 17920954 | Background | 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. |
| 27284521 | Background | 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. |
| 17908877 | Background | 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. |
| 25749653 | Background | 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. |
| 25264512 | Background | 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. |
| 30167363 | Background | 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. |
| 24379730 | Background | 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. |
| 17721778 | Background | 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. |
| 18196393 | Background | 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. |
| 24114749 | Background | 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. |
| 19171272 | Background | 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. |
| 20130837 | Background | 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. |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided