The main objective of this study is to compare the femur tunnel positioning after AMP, TLS and TT reconstruction techniques. We will also look at the relation between tunnel positioning and tunnel widening.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percentage of correct positioned femur tunnels
using CT-analysis.
Secondary outcome
the secondary study parameter is the increase of tunnel diameter 1 year after
surgery using CT-analysis
Background summary
Anterior cruciate ligament (ACL) reconstruction techniques are continuously
changing. Anatomical reconstruction are the latest development. Anatomical
femur tunnel positioning has been shown to be an important predictor for the
clinical outcome. This has led to the development of new reconstruction
techniques. Multiple retrospective studies have shown that the anatomical
placement of the femur tunnel with the use of a the anteromedial portal (AMP)
and tape locking crew (TLS) reconstruction technique have a better short term
clinical outcome. Most studies show a significant difference between the
techniques, but not a clinical relevant difference. Randomized controlled
trials directly comparing both techniques with the standard transtibial (TT)
drilling technique aren*t available. There is now current data comparing the
location of the tunnel positioning en widening of tunnels between the three
different groups. Tunnel widening has been considered an early sign of graft
failure.
Study objective
The main objective of this study is to compare the femur tunnel positioning
after AMP, TLS and TT reconstruction techniques. We will also look at the
relation between tunnel positioning and tunnel widening.
Study design
randomised control intervention study
Intervention
ACL reconstruction with autograft or allogaft using AMP en TLS reconstruction
technique
Study burden and risks
both intervention operation procedures are considered safe and effective. A
recent study using the Danish Knee Ligament Reconstruction Register showed that
the AMP technique has a slightly increased risk (RR: 2.01) of revision surgery.
This was attributed due to the implementation of this new technique. The
surgeons participating in this study are well experienced with the TT and AMP
techniques and will be well trained in the TLS technique.
The burden for the participants in this study is minimal. The follow-up after
ACL reconstructive surgery is standardized in our hospital. The participants of
this study will undergo the same standardized follow-up. The patient will
undergo an addition CT-scan., 1 year after surgery. The CT-scan will increase
the radiation exposure with 0.16 mSV.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
- Patient older than 18 years and younger than 60 years old.
- Mentally competent to understand the informed consent.
- Clinical diagnosis of ACL rupture.
Exclusion criteria
- ACL rupture older than 6 months.
- Meniscus rupture larger than 25%
- Indication for meniscal repair.
- Injury of the collateral ligaments or posterior cruciate ligament
- History of ACL or meniscal rupture
- Neurological or systemic disorder that inhibit adequate rehabilitation
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 | NL43499.075.14 |