To conduct a randomised controlled trial to determine differences in outcomes of the TT and AMP ACL reconstruction techniques by means of MRI signal SI of the ACL graft. Secondly, differences in clinical, functional and patient-oriented outcomes of…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to conduct a randomised controlled trial
to determine differences in MRI SIR of the ACL graft following the transtibial
(TT) and anteromedial portal (AMP) ACL reconstruction drilling technique.
Secondary outcome
Clinical and functional outcomes will be assessed by The International Knee
Documentation Committee (IKDC) Knee Examination Form and patient-oriented
outcomes will be assessed by Knee injury and Osteoarthritis Outcome Score
(KOOS) assessment.
Additionally, MRI assessment with the current PDWI/PDWI SPAIR imaging protocol
will be compared to additional T2*WI gradient echo imaging protocol.
Background summary
Rupture of the anterior cruciate ligament (ACL) is a frequently seen (sport)
injury mostly induced by a non-contact deceleration motion and can be treated
by ACL reconstruction surgery. There are two primary surgical techniques to
reconstruct the ACL: transtibial (TT) technique or anteromedial portal (AMP)
technique. Currently, there is no evidence which surgical technique elicits the
best clinical and functional outcomes. However, these assessments are an
indirect measure of the graft integrity and require large numbers of patients
to detect differences between both operation techniques. There is a need for a
quantitative in vivo measurements method for the evaluation of the
biomechanical performance of the ACL graft. MRI-derived measures of the signal
intensity (SI) of the ACL graft have been described as an independent predictor
of graft properties. MRI assessment with proton density weighted imaging (PDWI)
fails to correlate with actual graft function. A more promising technique is
T2*-weighted gradient-echo MRI imaging which has been reported as a useful
imaging modality to assess graft integrity. This leads to our research
question: Is there a difference in SI of the ACL graft on MRI, one year after
ACL reconstruction, between TT and AMP reconstruction technique?
Study objective
To conduct a randomised controlled trial to determine differences in outcomes
of the TT and AMP ACL reconstruction techniques by means of MRI signal SI of
the ACL graft. Secondly, differences in clinical, functional and
patient-oriented outcomes of the TT and AMP ACL reconstruction techniques will
be assessed. Additionally, differences between MRI SIR assessment with the
current MRI protocol (PDWI and PDWI SPAIR imaging protocol) and the additional
T2*WI gradient echo protocol will be assessed.
Study design
A randomised controlled trial will be executed. Patients will be randomly
allocated to undergo ACL reconstruction by means of the TT and AMP drilling
technique. The trial will be conducted at the department of Orthopaedics of the
Martini Hospital Groningen.
Intervention
Patients in the study group will undergo ACL reconstruction using the AMP
technique. This technique will be compared to the conventional TT technique for
ACL reconstruction in the control group.
Study burden and risks
Since both the TT and AMP technique for ACL reconstruction are standard
techniques for ACL reconstruction, no additional risks are associated with
participation of the study. No additional risks are involved with the MRI.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 and 60 years
- A proven ACL rupture confirmed by means of arthroscopy or MRI scan
Exclusion criteria
- a history of previous surgery on the ipsilateral knee
- re-rupture of the ipsilateral ACL graft
- associated ligamentous injuries or meniscal tear of the ipsilateral knee
- unhealthy contralateral knee
- contra-indications for MRI
- preference for one of the two surgical techniques and/or orthopaedic surgeon
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL54568.099.15 |
OMON | NL-OMON28419 |