Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Rupture
• Interventions: Procedure: Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)

• Registration Number: NCT05673356
• Lead Sponsor: Artromedical Konrad Malinowski Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-28
• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm of the study	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.

Primary Outcome Measures

Name	Time	Method
Knee stability	At the 24 month of the follow-up.	Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.

Secondary Outcome Measures

Name	Time	Method
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)	At the 24 month of the follow-up.	Min of 0 max of 87 points, higher scores mean a better outcome
ROM	At the 24 month of the follow-up.	Knee range of motion assessed by the means of goniometer.
Retear rate	At the 24 month of the follow-up.	Rate of patients with retear of the reconstructed ligament
The functional assessment with the Knee injury and Osteoarthritis Outcome Score	At the 24 month of the follow-up.	Min of 0 max of 100 points, higher scores mean a better outcome

Trial Locations

Locations (1)

Artromedical Orthopaedic Clinic; 🇵🇱 Bełchatów, Łódzkie, Poland