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Onderzoek naar de draaistabiliteit van de knie na reconstructie van de voorste kruisband.

- candidate number14491
- NTR NumberNTR3892
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2013
- Secondary IDsNL40420.068.12 / 12-3-023; METC azM/UM / METC Atrium-Orbis-Zuyd
- Public TitleOnderzoek naar de draaistabiliteit van de knie na reconstructie van de voorste kruisband.
- Scientific TitleIn vivo analysis of tibial rotation after anatomical versus trans-tibial anterior cruciate ligament reconstruction surgery.
- hypothesisTheoretically 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.
- Healt Condition(s) or Problem(s) studiedAnterior cruciate ligament, Stability
- Inclusion criteriaUniversal 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 criteriaUniversal 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 2-apr-2013
- planned closingdate30-jul-2013
- Target number of participants80
- InterventionsThe 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.
- Primary outcomeOur 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 outcomeAdditionally, 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.
- TimepointsOn 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
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Orbis Medisch Centrum, Orthopedic Department
- Funding
(Source(s) of Monetary or Material Support)
Orbis Medisch Centrum
- PublicationsN/A
- Brief summaryExperiments 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.
- Main changes (audit trail)
- RECORD14-mrt-2013 - 20-mrt-2013

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