|- candidate number||24237|
|- NTR Number||NTR5830|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-apr-2016|
|- Secondary IDs||NL57502.100.16 |
|- Public Title||Dynamische computer tomografie voor de beoordeling van de knie rotatie instabiliteit na posterior-lateraal hoekletsel. |
|- Scientific Title||Dynamic Computed Tomography for assessment of Knee Rotational Stability after Posterolateral corner injury|
|- Healt Condition(s) or Problem(s) studied||Computed tomography, Knee|
|- Inclusion criteria||• Speak, understand and read Dutch.|
• Uni-lateral symptomatic knee instability and PLC deficiency.
• Planned for PLC reconstruction surgery
• Symmetric (left- right) long leg axes
• Age between 18 – 50 years
• A written informed consent should have been signed
|- Exclusion criteria||• Rheumatoid arthritis or systemic inflammatory disease|
• Previous operation on the knee
• Symptomatic contra-lateral knee
• Prior injury to contra-lateral knee
• Patient is unwilling to participate
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jun-2016|
|- planned closingdate||1-jun-2017|
|- Target number of participants||10|
|- Interventions||There will be no additional or altered treatment of the subjects. One dynamic-CT scan (diagnostic) of each knee will be performed.|
|- Primary outcome||Difference in rotational stability in degrees as measured by dynamic-CT of intact compared to injured PLC knees.
- Is the view of the scanner wide enough for a dynamic scan of the knee? During motion the centre of the knee should not move out of the image centre.
- Are the images of the knee large enough for the image processors to fit the knee coordinate systems onto the images?
- Is this method technical possible and feasible in the normal clinical setting and suited for daily clinical practice?
|- Secondary outcome||Amount of rotational stability as assessed by dynamic-CT compared to patient functional outcome measures and patient satisfaction measured by questionnaires.
Amount of rotational stability as measured by dynamic-CT compared to physical examination (dial test).
|- Timepoints||one time point: preoperatively|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Nienke Wolterbeek|
|- CONTACT for SCIENTIFIC QUERIES|| Nienke Wolterbeek|
|- Sponsor/Initiator ||St. Antonius Hospital|
(Source(s) of Monetary or Material Support)
|St Antonius Hospital, Nieuwegein|
|- Brief summary||Rationale: Posterolateral corner (PLC) injury is one of the most serious knee injuries in the young athlete. The PLC provides stability of the knee in rotation and varus stress. The reconstruction of the PLC complies two main goals, namely restoration of varus stability and restoration of rotational stability. Though, we cannot measure the rotational stability of the knee reliable for there is currently no reliable technique available. New generation Computed Tomography (CT) scanners (dynamic-CT) make it possible to assess moving joints in a quantitative manner. This technique might provide essential information of knee rotational stability before and in a later stage after PLC reconstruction and hereby, possibly prediction of patient satisfaction after PLC repair. |
Objective: To assess the rotational stability of the knee using dynamic-CT scanning.
Study design: A feasibility study / pilot study. It will be a cross-sectional design, using the contralateral knee as control group (reference). A dynamic-CT scan will be performed of the injured as well as the uninjured knee to assess the differences in rotations.
Study population: 10 patients planned for PLC reconstruction surgery, with a unilateral symptomatic PLC deficiency will be included, 18-50 years of age.
Intervention: All participants will undergo one dynamic-CT scans of each knee, left and right, prior to PLC reconstruction.
Main study parameters/endpoints: Degrees of rotation (femur versus tibia) of the injured versus the uninjured knee. Is it possible to measure the present different using a dynamic-CT scan.
|- Main changes (audit trail)|
|- RECORD||14-apr-2016 - 22-jun-2016|