Clinical trial NCT05673356: Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
Official title: Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Lead sponsor: Artromedical Konrad Malinowski Clinic
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group: Clinical trials with a single arm.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Knee stability
timeFrame: At the 12 month of the follow-up.
measure: Knee stability
timeFrame: At the 24 month of the follow-up.
Secondary outcomes:
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
timeFrame: At the 24 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score
timeFrame: At the 12 month of the follow-up.
measure: The functional assessment with the Knee injury and Osteoarthritis Outcome Score
timeFrame: At the 24 month of the follow-up.
measure: Retear rate
timeFrame: At the 12 month of the follow-up.
measure: Retear rate
timeFrame: At the 24 month of the follow-up.
measure: ROM
timeFrame: At the 12 month of the follow-up.
measure: ROM
timeFrame: At the 24 month of the follow-up.
Other outcomes:
Locations:
city: Bełchatów
country: Poland
facility: Artromedical Orthopaedic Clinic
state: Łódzkie
Study officials:
affiliation: Artromedical Orthopaedic Clinic, Bełchatów, Poland
name: Konrad Malinowski, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.