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…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Failure= presence of pathological laxity, complaints of knee instability in the
absence of any pathological laxity and/or discontinuïty of the graft on MRI or
arthroscopy.
Secondary outcome
Secondary outcome measures and study parameters are displayed below. Follow-up
measurements are perfomed at 6 weeks, 6 months, 1, 2, 5 and 10 years
postoperatively.
Secondary outcomes
• ACL-QOL
• Failure
• IKDC 2000 subjective knee evaluation score
PROM's
• KOOS (Knee injury and Osteoarthritis Outcome Score), demographic form,
current health assessment form, knee history form
• Tegner Score
• Lysholm Score
• VAS Anterior Knee Pain score during rest
• VAS Anterior Knee Pain score during activity
• VAS Kneeling Pain score
• VAS Contentment score
Clinimetrics
• IKDC 2000 physical examination score
• Instrumented anteroposterior laxity (Rolimeter)
• Leg Symmetry Index (LSI) jump tests
Radiology
• Kellgren-Lawrence (KL) score
Other
• Monitoring and registration of standard side effects, complications and/or
new knee injuries (contact or non-contact) that occur during the whole study,
when relevant in relation to specific details from the surgery reports.
optionally:
Patiënts from OCON will be asked to wear movement sensors during the execution
of the regular hop tests (6 months, 1 jaar en 2 jaar) in order to be able to
more objectively examine knee (flexion/extension, valgus/varus), ankle en hip
angles.
Background summary
Background
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, anno 2014 there 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 standard.
Nowadays, the philosophy of isometric tunnel placement has been abandoned, and
has been replaced by the philosophy of anatomic reconstructions.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?
The hamstring autograft is currently the most used graft for ACL reconstruction
worldwide, despite 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 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 treatment, and the
possibility to generalise 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 of the patella tendon
graft, still 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 patellatendon
and hamstring autograft. Functional outcome is similar, while less donorsite
morbidity is reported compared to the patellatendom 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 anatomic 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
The hypothesis is that anatomic reconstruction of the 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
patellatendon autograft or a hamstringtendon 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 MRI or arthroscopy.
Study objective
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 patellatendon autograft or a hamstringtendon autograft, in terms of failure,
measured 2 years postoperatively. Failure is defined gedefinieerd as
pathological laxity, complaints of knee instability in the absence of any
pathological laxity and/or discontinuïty of the graft on MRI or arthroscopy.
Secondary objectives:
patient 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 patient 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 and12 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=2, 4, 6, 8). Patients with an anterior cruciate ligament rupture,
confirmed by an orthopaedic surgeon (as evident from anamnesis, physical
examination and radiographic imaging) who fit the inclusion criteria and do not
have any of the exclusion criteria, will be asked to participate 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 patellatendon autograft,
hamstring tendon autograft or quadricepstendon 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 and 12 months, 2 years. Two extra follow-up moments (after 5
and 10 years) will be planned.
Intervention
Patients who are included in this study will be randomly assigned for ACL
reconstruction with one of the three grafts: hamstring autograft, patella
autograft or quadriceps autograft. Stratification will be based on age (18-25
years old and >25 years old), surgeon, and on level of activity (Tegner score).
Study burden and risks
Both the surgery and the rehabilitation will be conducted according to the
standard protocol of the two hospitals. Participation in this study does lead
to extra risk. Relevant risks for patients are the standard risks of an ACL
reconstruction. These will be the same for patients that do not participate in
this study. All grafts have specific risks and benifits, as described in
Chapter 1 of the protocol "Introduction and rationale". Patients are informed
and educated about these risks and benifits by the orthopaedic surgeon, prior
to the choice of participation in this study. The benefits of each graft
surpass the potential risks for said graft in all three graft types.
This study focussus on the evaluation of three types of surgical treatment.
Therefore, this study can only be conducted with patients who require such an
intervention.
Geerdinksweg 141
Hengelo 7555 DL
NL
Geerdinksweg 141
Hengelo 7555 DL
NL
Listed location countries
Age
Inclusion criteria
• Patients active in sports, Tegner =/>5
• Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRI
• Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supervised by a NFVS registerd sport-physical therapist
• <6 months between initial trauma and surgery
Exclusion criteria
• History of knee surgery on the same side
• History of tendon removal on the same side
• Accompanying ligament injury of the knee, evident from anamnesis, physical examination, radiograph and MRI, defined as an ACL rupture in combination with a posterior cruciate ligament or collateral ligament injury,
• Peroperative discovery of cartilage damage; larger than 2cm2 and more than 50% depth
• Peroperative discovery of meniscus injury which requires a meniscectomy of more than 20% or meniscus sutures
• Osteoarthritis of Kellgren and Lawrence grade 2 or more, as evident from the radiograph
• Severe malalignment of the leg
• Tendency to form excessive scar tissue, such as arthrofibrosis
• Muscular, neurological or vascular anomalies that influence healingtime or rehabilitation
• Infection
• Known hypersensitivity to any of the used materials
• Long term relevant medication use such as prednisolone or cytostatics
• Pregnancy at the time of inclusion or surgery
• Known osteoporosis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52749.044.16 |
| Other | trialregister |