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Het doel van het onderzoek is om een beter beeld te krijgen van de stabiliteit van knieën met een intacte kruisband, een afgescheurde kruisband, een anatomisch en transtibiaal gereconstrueerde kruisband.
The aim of the research is to better understand the stability of knees with an intact ACL, an defecit ligament, an anatomical and transtibial reconstructed ACL ligament.
Sponsors and support
Orbis Medisch Centrum
Dep. Orthopedie
dr Hvd Hoffplein 1
6162 BA Sittard-Geleen
(+31) (0)88 459 7823
Intervention
Outcome measures
Primary outcome
Our first outcome of interest will be the tibial rotation excursion. This is the graph which we can draw from our gait analysis system which measures the position of the tibia in relation to that of the femur and allows us to see the angle of rotation.
Secondary outcome
Additionally, we keep track of our patients' well-being and satisfaction using several questionnaires. We will use questionnaires and clinical tests that have been recommended by the Nederlandse Orthopaedische Vereniging (NOV):
1. Knee Injury and Osteoarthritis Outcome score (KOOS) (Questionnaire);
2. International Knee Documentation Committee (IKDC) (Questionnaire);
3. Tegner sports activity score
(Questionnaire);
4. Lachman Test
(Clinical Test);
5. Anterior Drawer Test
(Clinical Test);
6. Pivot Shift Test
(Clinical Test).
We will also take several other values into account that the VICON system generates automatically when we perform our 3D gait analysis:
1. Dynamic EMG Measurement;
2. Knee moments;
3. Foot approach angle.
Background summary
Experiments dealing with the rotational stability after an ACL reconstruction have not been performed in vivo or were performed under static conditions. Although static rotational stability testing is currently the standard, many studies have shown that static stability tests are often incapable of correlating with functional outcome following anterior cruciate ligament-reconstruction-surgery. Through in vivo testing in dynamic weight bearing knees we expect to get a better view of the actual rotational pivoting forces in the knee.
Participants will be recruted by Dr P Deckers (MD) from the Dep. of Orthopedic surgery Atrium MC in Heerlen, Dr P Emans (MD, PhD) from the Dep. of Orthopedic surgery AZM in Maatricht and Dr EJP Jansen (MD, PhD) from the Dep. of Orthopedic surgery Orbis MC in Sittard-Geleen.
Study objective
Theoretically the anatomical reconstruction technique might give better results in rotational stability due to a more anatomical placement of the ACL-graft. Though it is difficult to test this correlating to functional outcome, because in current literature there seems to be no significant difference between both surgical techniques. Moreover, statically performed anterolateral rotational instability tests do not reproduce the forces loaded onto an in vivo anterior cruciate ligament. Through in vivo kinematic 3D- gait analysis, we aim to measure statistically and clinically significant differences in tibial rotational excursion when patients perform several motor tasks.
Study design
On the Gait-lab test day participants will be required to come to the Maastricht University Movement Laboratory. On this day they will follow the regimen described below.
Test day Schedule:
1. Physical examination (5-10 minutes);
2. EMG placement and maximum force determination (10-15 minutes);
3. Skin marker placement (5-10 minutes);
4. Skin marker calibration (5-10 minutes);
5. Vicon Gait analysis (10 minutes);
6. Questionaires (10-20 minutes).
Total time 35-55 (47-75) minutes
Intervention
The transtibial ACL reconstruction. In this technique the orientation of the femoral tunnel depends on the orientation of the tibial tunnel, because the femoral tunnel is created through the tibial tunnel. In this way a non-anatomical reconstruction is performed.
The anatomical ACL reconstruction aims to better restore this rotational stability by placing an extra anteromedial arthroscopy portal through which the femoral tunnel can be reamed more laterally and more diagonally oriented, hereby placing the graft in a more anatomical orientation similar to the native ACL.
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
dr H vd Hoffplein 1
M.G.M. Schotanus
Geleen 6162 BG
The Netherlands
+31 (0)88 4597823
m.schotanus@zuyderland.nl
Inclusion criteria
Universal Inclusion criteria:
1. Age 18-40 years;
2. Able to understand and speak the Dutch or English language.
Healthy Control group:
1. No history of knee ligament or meniscal injury.
ACL Deficient Group:
1. Diagnosed ACL rupture with MRI or surgical knee arthroscopy;
2. Primary ACL rupture.
Transtibial Reconstruction group:
1. Received transtibial ACL reconstruction minimally one year ago.
Anatomical Reconstruction group:
1. Received anatomical ACL reconstruction minimally one year ago.
Exclusion criteria
Universal Exclusion criteria:
1. Not able and willing to sign informed consent;
2. BMI > 30.
ACL Deficient Group:
1. Ligament injury to the contralateral knee.
Transtibial Reconstruction group:
1. Ligament injury to the contralateral knee.
Anatomical Reconstruction group:
1. Ligament injury to the contralateral knee.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3729 |
| NTR-old | NTR3892 |
| CCMO | NL40420.068.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39154 |