Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
Primary Purpose
Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear
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
Sites / Locations
- Artromedical Orthopaedic ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Main arm of the study
Arm Description
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients.
Outcomes
Primary Outcome Measures
Knee stability
Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.
Knee stability
Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.
Secondary Outcome Measures
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
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
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Min of 0 max of 100 points, higher scores mean a better outcome
Retear rate
Rate of patients with retear of the reconstructed ligament
Retear rate
Rate of patients with retear of the reconstructed ligament
ROM
Knee range of motion assessed by the means of goniometer.
ROM
Knee range of motion assessed by the means of goniometer.
Full Information
NCT ID
NCT05673356
First Posted
January 4, 2023
Last Updated
January 9, 2023
Sponsor
Artromedical Konrad Malinowski Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05673356
Brief Title
Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
Official Title
Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Artromedical Konrad Malinowski Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group: Clinical trials with a single arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main arm of the study
Arm Type
Experimental
Arm Description
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB) will be performed in these patients.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic anterior cruciate ligament reconstruction with quadriceps tendon bone autograft (QTB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee stability
Description
Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.
Time Frame
At the 12 month of the follow-up.
Title
Knee stability
Description
Anterior and anterolateral rotatory knee stability assessed by the means of instrumented Lachman test and pivot-shift test.
Time Frame
At the 24 month of the follow-up.
Secondary Outcome Measure Information:
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the The International Knee Documentation Committee Questionnaire (IKDC)
Description
Min of 0 max of 87 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 12 month of the follow-up.
Title
The functional assessment with the Knee injury and Osteoarthritis Outcome Score
Description
Min of 0 max of 100 points, higher scores mean a better outcome
Time Frame
At the 24 month of the follow-up.
Title
Retear rate
Description
Rate of patients with retear of the reconstructed ligament
Time Frame
At the 12 month of the follow-up.
Title
Retear rate
Description
Rate of patients with retear of the reconstructed ligament
Time Frame
At the 24 month of the follow-up.
Title
ROM
Description
Knee range of motion assessed by the means of goniometer.
Time Frame
At the 12 month of the follow-up.
Title
ROM
Description
Knee range of motion assessed by the means of goniometer.
Time Frame
At the 24 month of the follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konrad Malinowski, MD PhD
Phone
+48 509812212
Email
malwin8@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Organizational Affiliation
Artromedical Orthopaedic Clinic, Bełchatów, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artromedical Orthopaedic Clinic
City
Bełchatów
State/Province
Łódzkie
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad Malinowski, MD PhD
Phone
+48 509 812 212
Email
malwin8@wp.pl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33981566
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.
Results Reference
background
PubMed Identifier
31704697
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.
Results Reference
background
PubMed Identifier
25543249
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.
Results Reference
background
PubMed Identifier
31305357
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.
Results Reference
background
PubMed Identifier
24630956
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.
Results Reference
background
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Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Bone Autograft
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