Primary objective: To estimate the incidence of clinical and radiological DRUJ instability after a conservatively treated distal radius fracture using clinical tests and CT-scan, and to assess the value of CT for diagnosing DRUJ instability using…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
DRUJ instability confirmed by physical examination (stress test or clunck test
positive) and CT-scan.
Static clinical DRUJ instability will be diagnosed with the stress test. The
test is positive if there is more anterolateral movement of the ulna, relative
to the stabilized radius than compared to uninjured wrist. Dynamic clinical
DRUJ instability will be diagnosed by the clunck test. During passive rotation
of the wrist the ulna is compressed to the radius. This test is positive if a
clunck is palpable for the subject.
DRUJ instability will be evaluated on the CT-scan of both wrist in maximal pro-
and supination as described by the subluxation ratio [46]. Two lines
perpendicular to a line connecting the volar and dorsal margins of the sigmoid
notch are drawn from the volar and dorsal margins of the sigmoid notch. The
ratio of the length of CD to that of AB is calculated. (Fig. 1). Normal values
are 0.2, 0.01 and -0,13 in maximal pronation, neutral and maximal supination
respectively.
Secondary outcome
o Wrist function
Physical examination will include determination of restricted or blocked
pronosupination, ulnar and radial deviation, dorsal and palmar flexion using a
goniometer, and grip and pinch strength using a JAMAR® Hydraulic Hand
Dynamometer and JAMAR® Hydraulic Pinch Gauge. For each patient maximal range
of motion in any direction will be tested three times and measured by a
goniometer. Both maximal grip and pinch strength, with the elbow in 90dgrs of
flexion and shoulder in neutral position will be measured three times. The
average of the three measurements will determine function. Loss of function is
defined as 10% or more decrease in arc of motion (pro- and supination,
ulnar-radial deviation and palmar-dorsal flexion) compared to the uninjured
side.
o Malunion
Malunion is defined as the difference in radial length, radial inclination and
volar tilt as confirmed on the CT, comparing the injured with the uninjured
wrist. More than 10% difference is considered malunion.
o Pain
Pain is indicated on a 100-point visual analogue score. Patients will be asked
to indicate their pain four times for each wrist; first time without
loadbearing, the second time imagining bearing a 10kg weight. Both in rest and
movement.
o Subjective health assessment
Subjective assessments of quality of life and wrist function will be obtained
using the Mayo modified wrist score [5], Gartland and Werley score [15],
Disabilities of the Arm, Shoulder and Hand (DASH) [23] and Short Form-36
(SF-36) [25]. Patients can fill them out at home or during their visit.
o Associated unknown traumatic changes
Associated unknown traumatic changes (additional ligamenteous or osseous
changes) on CT-scan are defined as traumatic changes not mentioned on the
existing investigations, nor intentionally treated during follow-up.
o Complications
Complications are defined as adverse medical responses after the treatment of
the distal radius fracture during follow-up.
o Radiocarpal and DRUJ arthrosis
Arthrosis is defined as loss of cartilage and will be scored on CT according to
the classification of Knirk and Jupiter. [32]
The kappa measure (*) and intra-class correlation coefficient will be computed
to estimate inter-observer and intra-observer agreement for CT parameters. [10,
33, 56, 61] The values will be interpreted using the guidelines proposed by
Landis and Koch [33]: values of 0.01 to 0.20 indicate slight agreement; 0.21 to
0.40, fair agreement; 0.41 to 0.60, moderate agreement; 0.61 to 0.80,
substantial agreement; and more than 0.81, almost perfect agreement. Zero
indicates no agreement beyond that expected due to chance alone, * 1.00 means
total disagreement, and + 1.00 represents perfect agreement [33, 56].
Background summary
Rationale:
In up to 1/3 of patients suffering from a distal radius fracture wrist function
is decreased due to DRUJ instability after long term follow-up. DRUJ
instability is caused by disruption of the stabilizing structures of the distal
radioulnar joint of which the TFCC is the most important. Disruption of the
attachment of the TFCC to either the ulnar styloid or ulnar fovea may cause
instability. However DRUJ instability after a distal radius fracture has also
been described with an intact TFCC. Another risk factor is more than 15° of
dorsal angulation of the distal radius.
Clinical DRUJ instability is either static or dynamic. Static instability is
confirmed by stressing the stabilizers without rotation of the forearm, whereas
in testing for dynamic instability rotational forearm movements are made.
Without sedation these tests are useless in the acute setting because of pain
and swelling. Radiological DRUJ instability can, among others, be confirmed by
radiographs or CT-scan of the wrist. Major limitation of using these modalities
is that these show the static reflection of a dynamic process, which may give
rise to false negative outcomes. Furthermore in literature data on the
association between clinical and radiological presentation is scarce.
Therefore the aim of this study is to obtain more insight into the incidence
and predictability of DRUJ instability after a conservatively treated distal
radius fracture.
Study objective
Primary objective: To estimate the incidence of clinical and radiological DRUJ
instability after a conservatively treated distal radius fracture using
clinical tests and CT-scan, and to assess the value of CT for diagnosing DRUJ
instability using clinical tests as reference standard.
Secondary objectives:
* To assess the predictive value of risk factors on trauma radiographs for
clinical and CT-measured DRUJ instability after consolidation of a distal
radius fracture.
* Analysis of radiological traumatic changes (missed fractures, artrhosis) in
patients with clinical DRUJ instability by comparing the injured with the
uninjured wrist.
* Determination of complications after conservative treatment of distal radius
fractures in short- and long term follow-up.
* Determination of inter- and intra-observer agreement on diagnosing DRUJ
instability using CT.
Study design
a single-center, descriptive cohort study.
Study burden and risks
All subjects are free to participate, and to exit the study at any moment.
The subjects will not benefit from participation in the study. However, the
subjects who are symptomatic but did not seek medical treatment so far, may
benefit from the functional measurements and additional radiologic
investigations, because these may attribute to the diagnosis and may lead to an
intervention to relief their symptoms.
The included patients have to visit our hospital for approximately 45 minutes
to complete the investigations, including radiography, physical examination and
filling out the questionnaires. The patient will receive refunds for the
travelling costs and parking.
During the CT-scan, the patient will suffer from a small amount of radiation
(0.03 mSv). Since the CT-scan will give particular additional information, it
cannot be replaced.
A standardized questionnaire to evaluate CT-associated risk-factors will be
filled out before the investigation will be started.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* radiographically proven distal radius fracture in the period 2008-2010, conservatively treated in the LUMC
* age > 18 years
* distal radius consolidation, as confirmed on radiographs.
Exclusion criteria
* unwilling or unable to provide informed consent to participate in this study
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 | NL41495.058.12 |