Primary Objective: To determine the varus and valgus laxity in extension (0 *), mid-flexion (30 *) and flexion (90 *) in the normal older healthy knee from subject equal aged to the population of patients who received a total knee prosthesis in the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is varus and valgus laxity of the knee at 0 *, 30 *
and 90 * flexion. For varus and valgus flexion a custom made stress device will
be used to stress the knee. With this device the subject lay supine with
his/her lower leg on a plateau with the knee flexed in 0 *, 30 * and 90 *. With
the use of a 5 kilogram weight at 30 cm from the joint line and a pulley a
moment of 15 Nm will be applied at the knee joint. The knee will stressed
medially and laterally. For each subject, nine roentgenograms (three in 0 *,
three in 30 * and three in 90 *) will be taken with medial, lateral and no
stress applied, under fluoroscopic guidance with the roentgen ray direction
parallel to the tibia joint surface.
Secondary outcome
* Demographic data
* Patient reported outcome score: Tegner activity score
* Clinician reported outcome score:
* - Knee Society Score assessed as defined by
Insall
* - Anterior and posterior translation of the tibia was
measured in 20 *, 30 * and 90 * flexion using the Rolimeter.
* Functional outcome:
* Knee power output measured with the Leg Extensor Power Rig
Background summary
The aim of TKA using a ligament-guided implantation technique is to restore
knee function and kinematics of the arthritic knee to a normal, healthy level,
on guidance of the intact knee ligaments. Therefore reference values of an
equal aged healthy (non-arthritic) control group were needed to compare these
values with the TKA population. Heesterbeek et al. (2006) performed a study to
quantify the amount of varus and valgus laxity in extension and flexion (70 *)
in the healthy older knee.
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Study objective
Primary Objective:
To determine the varus and valgus laxity in extension (0 *), mid-flexion (30
*) and flexion
(90 *) in the normal older healthy knee from subject equal aged to the
population of patients who received a total knee prosthesis in the Sint
Maartenskliniek.
Secondary Objective(s):
The secondary objective of this study is to assess AP-laxitiy, the Knee Society
Clinical and Functional Rating System and Knee function measured with the Leg
Extensor Power Rig of the normal older, non-arthritic knee.
Study design
The present study is a cross sectional study to determine reference values of
knee laxity measured at 0 *, 30 * and 90 * flexion in the normal older
healthy knee from subjects equal aged to the population of patients who
received a TKA. Participants will be assessed at one occasion.
Study burden and risks
Healthy subjects are asked to visit our clinic once. The extra amount of time
that a subject invests in the study is about 1 hour. Prior to the visit the
subjects are asked to fill in the questionnaire, during the visit X-rays will
be taken. Questionnaires do not bring any extra burden. The radiation of nine
radiographs will be set to a minimum and therefore the total amount of
radiation falls within the limits of the IRP (International Commission of
Radiological Protection.) The Leg extensor power rig is a standardized and save
device used for measuring knee function power output.
Hengstdal 3
Nijmegen 6500 GM
NL
Hengstdal 3
Nijmegen 6500 GM
NL
Listed location countries
Age
Inclusion criteria
* Subject is between 50 and 75 years old
* Subject has nog osteoarthritis or rheumatoid arthritis in one or both knees
* Subject has no history of knee injury, especially knee ligament injury
* Subject is living independently (e.g. not in a nursing home)
* Subject is able to walk for at least 1 hour without support (indicating good knee function)
Exclusion criteria
* Subject has a hip arthrodesis
* Subject has a hip prosthesis
* Subject has a BMI >35
* Subject has knee flexion <90 *
* Subject has ligament problems or varus or valgus leg
* Subject has low bone density
* Subject lives further than 50 km from the Sint Maartenskliniek
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 | NL55385.048.15 |