Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673356
• Other study ID #: 2-pro-ar-2022
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Artromedical Konrad Malinowski Clinic
• Contact: Konrad Malinowski, MD PhD
• Phone: +48 509812212
• Email: malwin8[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anterior cruciate ligament injuries are one of the most common sports knee injuries. Their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. Therefore, anterior cruciate ligament reconstruction (ACLR) is often indicated. Multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. Two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; ST or STG) and patellar tendon with two bone blocks (bone - patellar tendon - bone; BPTB). However, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (QT). Multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. Another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, QTB). The aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (QTB) used in ACLR. The primary outcome consists of The International Knee Documentation Committee Questionnaire (IKDC), the Knee injury and Osteoarthritis Outcome Score (KOOS) and retear rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic knee anterior and rotatory instability after ACL injury;
• Primary ACLR cases

Exclusion Criteria:

• Active inflammation of the knee;
• Revision cases;
• Additional PLC, PCL or PFJ injuries (MCL and meniscal lesions are not exclusion criteria);
• Fractures around the knee

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients. QTB autografts will be harvested as described in the published technique: K. Malinowski, J. Paszkowski, M. Mostowy, A. Góralczyk, R.F. LaPrade, K. Hermanowicz, Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools, Arthrosc. Tech. 10 (2021) e1165-e1172. https://doi.org/10.1016/j.eats.2021.01.003. ACLR will be performed utilizing anteromedial technique with management of any accompanying intraarticular lesions.

Locations

Country	Name	City	State
Poland	Artromedical Orthopaedic Clinic	Belchatów	Lódzkie

Sponsors (1)

Lead Sponsor	Collaborator
Artromedical Konrad Malinowski Clinic

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Lind M, Nielsen TG, Soerensen OG, Mygind-Klavsen B, Fauno P. Quadriceps tendon grafts does not cause patients to have inferior subjective outcome after anterior cruciate ligament (ACL) reconstruction than do hamstring grafts: a 2-year prospective randomised controlled trial. Br J Sports Med. 2020 Feb;54(3):183-187. doi: 10.1136/bjsports-2019-101000. Epub 2019 Nov 8. — View Citation

Lund B, Nielsen T, Fauno P, Christiansen SE, Lind M. Is quadriceps tendon a better graft choice than patellar tendon? a prospective randomized study. Arthroscopy. 2014 May;30(5):593-8. doi: 10.1016/j.arthro.2014.01.012. Epub 2014 Mar 14. — View Citation

Malinowski K, Paszkowski J, Mostowy M, Goralczyk A, LaPrade RF, Hermanowicz K. Quadriceps Tendon-Bone Full-Thickness Autograft: Reproducible and Easy Harvesting Technique Using Simple Surgical Tools. Arthrosc Tech. 2021 Mar 18;10(4):e1165-e1172. doi: 10.1016/j.eats.2021.01.003. eCollection 2021 Apr. — View Citation

Mehran N, Damodar D, Shu Yang J. Quadriceps Tendon Autograft in Anterior Cruciate Ligament Reconstruction. J Am Acad Orthop Surg. 2020 Jan 15;28(2):45-52. doi: 10.5435/JAAOS-D-19-00032. — View Citation

Slone HS, Romine SE, Premkumar A, Xerogeanes JW. Quadriceps tendon autograft for anterior cruciate ligament reconstruction: a comprehensive review of current literature and systematic review of clinical results. Arthroscopy. 2015 Mar;31(3):541-54. doi: 10.1016/j.arthro.2014.11.010. Epub 2014 Dec 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee stability	Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.	At the 12 month of the follow-up.
Primary	Knee stability	Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.	At the 24 month of the follow-up.
Secondary	The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)	Min of 0 max of 87 points, higher scores mean a better outcome	At the 12 month of the follow-up.
Secondary	The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)	Min of 0 max of 87 points, higher scores mean a better outcome	At the 24 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 12 month of the follow-up.
Secondary	The functional assessment with the Knee injury and Osteoarthritis Outcome Score	Min of 0 max of 100 points, higher scores mean a better outcome	At the 24 month of the follow-up.
Secondary	Retear rate	Rate of patients with retear of the reconstructed ligament	At the 12 month of the follow-up.
Secondary	Retear rate	Rate of patients with retear of the reconstructed ligament	At the 24 month of the follow-up.
Secondary	ROM	Knee range of motion assessed by the means of goniometer.	At the 12 month of the follow-up.
Secondary	ROM	Knee range of motion assessed by the means of goniometer.	At the 24 month of the follow-up.