Anterior Cruciate Ligament Injuries Clinical Trial
Official title:
Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction: Patella, Hamstrings or Quadriceps Tendon Autograft
A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current gold Standard treatment for young and active patients with instability, is a surgical ACL reconstruction. However, there still is no consensus on which graft is best suited for this.The aim of the current multi-center randomized controlled trial was to investigate the hypothesis that an anatomic single bundle anterior cruciate ligament reconstruction with a (flat) quadriceps tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or a hamstringtendon autograft, in terms of failure, measured 2 years postoperatively. Failure is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence of any pathological laxity and/or discontinuïty ofthe graft on MRl or arthroscopy.
A rupture of the anterior cruciate ligament (ACL) is a severe injury of the knee. The current
gold Standard treatment for young and active patients with instability, is a surgical ACL
reconstruction. However, there still is no consensus on which graft is best suited for this.
Paradigms on the different types of auto grafts and their weaknesses and benefits originate
mostly from the eighties and nineties, when the patella tendon was being replaced by the
hamstring graft as the 'new' gold standerd. Nowadays, the philosophy of isometrie tunnel
placement has been abandoned, and has been replaced by the philosophy of anatomie
reconstructions. The question then arises: Are the results of the comparative studies, and
the current paradigms, still applicable, now that the philosophy has transitioned from
isometric to anatomic tunnel placement? Irrespective of the disadvantages compared to the
patellatendon autograft, such as a higher re-rupture and revision percentage when used in
patients under 25 years old, the hamstring autograft is currently the most used graft for ACL
reconstruction worldwide. The question then arises: is it justified that the hamstringgraft
is the most used graft worldwide? Rehabilitation protocols are often not, or poorly,
described, despite it's significant effect on the outcome and co morbidity of an ACL
reconstruction. Especially anterior knee pain, which is often mentioned as a disadvantage of
the patellagraft, is significantly influenced by rehabilitation protocols. The introduction
and implementation of a nation-wide evidence-based rehabilitation protocol in The Netherlands
created uniformity of rehabilitation treatment, and the possibility to generalize scientific
conclusions. The question then arises: Due to new insights in rehabilitation and
implementation of new protocols, is the anterior knee pain, the often mentioned disadvantage
ofthe patelia tendon graft, stiil a relevant disadvantage? The quadriceps tendon autograft is
a less often used graft. Nevertheless, research has shown that it seems like a good
alternative for the patella tendon and hamstring autograft. Functional outcome is similar,
while less donorsite morbidity is reported compared to the patellatendon and hamstring
autograft. The question then arises: Is it fair that the quadriceps tendon is rarely used as
an autograft for ACL reconstruction? Increasing knowledge of the anatomy of the ACL results
in new insights in the methods to achieve true anatomie ACL reconstruction. New arguments
support the use of the patella tendon - and even the quadriceps tendon - over the use of the
hamstringgraft, because their anatomic similarities to the anterior cruciate ligament might
be better suited to restore knee kinematics. The question then arises: are the flat-shaped
patella tendon autograft and quadriceps tendon autograft better suited to restore the anatomy
of the ruptured ACL than the round hamstring graft? Hypothesis Tlie hypothesis is that
anatomic reconstruction ofthe ruptured anterior cruciate ligament with a (flat) quadriceps
tendon autograft is at least as effective as reconstruction of the ruptured anterior cruciate
ligament with a patella tendon autograft or a hamstring tendon autograft, in terms of
failure, measured 2 years postoperatively. Failure is defined as pathological laxity,
complaints of knee instability in the absence of any pathological laxity and/or discontinuïty
of the graft on MRl or arthroscopy.
Objective of the study:
Primary objective:
To investigate the hypothesis that an anatomic single bundle anterior cruciate ligament
reconstruction with a (flat) quadriceps tendon autograft is at least as effective as
reconstruction of the ruptured anterior cruciate ligament with a patella tendon autograft or
a hamstring tendon autograft, in terms of failure, measured 2 years postoperatively. Failure
is defined gedefinieerd as pathologicai laxity, complaints of knee instability in the absence
of any pathological laxity and/or discontinuïty of the graft on MRl or arthroscopy.
Secondary objectives:
patiënt reported outcome measures (PROMs), clinimetrics, radiological assessment, duration of
rehabilitation necessary for return to sports and daily activities and the level of sport
activities to which the patiënt returned, in patients treated with an anterior cruciate
ligament reconstruction using a patellatendon autograft, hamstringtendon autograft of
quadricepstendon autograft, as measured in the short-term (6 weeks, 6,9,12 months
postoperatively), mid-term (2 years postoperatively) and long-term (5 and 10 years
postoperatively).
Study design:
Multicenter blocked stratified randomised controlled trial with varying block sizes (n=3, 6,
9, 12). Patients with an anterior cruciate ligament rupture, confirmed by an orthopaedie
surgeon (as evident from anamnesis, physical examination and radiographic imaging) who meet
the inclusion criteria and do not have any of the exclusion criteria, will be asked to
partieipate in this study.
Baseline measurements will be performed, after informed consent is obtained. Allocation of
treatment of the included patients will be performed in the operating room (OR), where
patients will be randomised (blocked and stratified) per clinic, to have ACL reconstruction
with a patella tendon autograft, hamstring tendon autograft or quadriceps tendon autograft.
Stratification will be based on age (18-25 and >25), level of sport activities (Tegner
Activity Level Scale 5-7 and 8-10) and surgeon.
Follow-up identical to the follow-up of standard care, with standard checkups after 6 weeks,
6, 9, months and 1 and 2 years. Two extra follow-up moments (after 5 and 10 years) will be
planned.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04062578 -
Effects Provided by a Physiotherapy Treatment Preventing Lower Extremity Injuries in Female Football Players
|
N/A | |
Recruiting |
NCT05461326 -
Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT
|
N/A | |
Completed |
NCT05109871 -
Reliability and Validity of Inline Dynamometry Study for Measuring Knee Extensor Torque
|
N/A | |
Recruiting |
NCT05504018 -
Clinical and Radiological Evaluation of ACL Reconstruction Results
|
N/A | |
Recruiting |
NCT06185231 -
Investigation of the Effects of Vibration Therapy on Pain, Functionality, and Proprioception After ACL Injury
|
N/A | |
Recruiting |
NCT03968913 -
Biologic Therapy to Prevent Osteoarthritis After ACL Injury
|
Early Phase 1 | |
Completed |
NCT04408690 -
Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury
|
Phase 3 | |
Recruiting |
NCT06222814 -
Evaluation of the Results of Two Different Methods in Management of Antero-lateral Instability of the Knee
|
N/A | |
Recruiting |
NCT05614297 -
Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
|
||
Active, not recruiting |
NCT05184023 -
The Effect of PEMF for Patients With Quadriceps Muscle Weakness After ACLR
|
N/A | |
Completed |
NCT04906538 -
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique
|
Phase 2/Phase 3 | |
Completed |
NCT05014009 -
The Influence of Neuromuscular Training on Whole-body Movement Strategies and Knee Mechanics During Change-of-direction Tasks in Sports Science Students
|
N/A | |
Not yet recruiting |
NCT06083818 -
Anterior Cruciate Ligament Injury Prevention Protocol in Female Football Players With Dynamic Knee Valgus
|
N/A | |
Recruiting |
NCT05584020 -
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
|
N/A | |
Completed |
NCT04580290 -
Jewel ACL Post Market Clinical Follow Up Study
|
||
Recruiting |
NCT04888052 -
Prolonged Preoperative Rehabilitation in ACL Rupture.
|
N/A | |
Not yet recruiting |
NCT05580133 -
All-Inside Single-Bundle for Anterior Cruciate Ligament Reconstruction With Full Thickness of the Peroneus Longus Tendon Compared to the Six-strand-hamstring Autograft (ACL)
|
||
Recruiting |
NCT04162613 -
Can Sensorimotor Function Predict Graft Rupture After ACL Reconstruction
|
||
Not yet recruiting |
NCT05619393 -
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
|
N/A | |
Recruiting |
NCT06201442 -
Post-Traumatic Knee Osteoarthritis Following Anterior Cruciate Ligament Reconstruction
|