Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

NCT05673356 | Unknown

• 1 other identifier: 2-pro-ar-2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (8)

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 12 month of the follow-up.

• The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)

  At the 24 month of the follow-up.

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score

  At the 12 month of the follow-up.

• The functional assessment with the Knee injury and Osteoarthritis Outcome Score

  At the 24 month of the follow-up.

• Retear rate

  At the 12 month of the follow-up.

Study Arms (1)

Main arm of the study

EXPERIMENTAL

Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients.

Procedure: Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)

Interventions

Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) PROCEDURE

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.

Main arm of the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active inflammation of the knee;
• Revision cases;
• Fractures around the knee

Sponsors & Collaborators

• Artromedical Konrad Malinowski Clinic: lead

Study Sites (1)

Artromedical Orthopaedic Clinic

Bełchatów, Łódź Voivodeship, 97-400, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 33981566 BACKGROUND

• 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.

  PMID: 31704697 BACKGROUND

• 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.

  PMID: 25543249 BACKGROUND

• 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.

  PMID: 31305357 BACKGROUND

• 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.

  PMID: 24630956 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Konrad Malinowski, MD PhD

  Artromedical Orthopaedic Clinic, Bełchatów, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konrad Malinowski, MD PhD

CONTACT

+48 509812212; malwin8@wp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Konrad Malinowski MD, Artromedical Konrad Malinowski Clinic

Model Details: Single Group: Clinical trials with a single arm.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 6, 2023
• Study Start: August 28, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)