The aim of this project is to assess objective impairment and arm-specific disability (DASH scores) in long-term follow-up of patients with diaphyseal fractures of both bones of the forearm treated with open reduction and plate and screw fixation,…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Primary Study Question: Does depression as measured by the CESD account for a
greater portion of the variability in DASH scores than forearm arc of motion?
Secondary outcome
* Secondary Study Questions:
What are the predictors of DASH scores from among the following:
depression, motion and radiographic measures?
Background summary
Internal fixation of both bones diaphyseal forearm fractures has been
associated with high union rates[1]. Healing occurs reliably after closed
reduction but malunion, with resultant decreased range of motion is a rare but
important complication. Stabilization with internal plate fixation restores
nearly normal anatomy and motion. However, a moderate reduction in strength
should be anticipated[1, 2].
The purpose of the study is to investigate long term objective and subjective
patient based outcomes. Secondly, univariate and multivariate analyses will be
performed to identify objective and subjective predictors of disability as
measured with the Disability of Arm, Shoulder and Hand (DASH), and the clinical
outcome according to the Modified Mayo Wrist Score (MMWS) [19] and the Modified
Gartland and Werley Score (MGWS).
Prior to the AO era of open reduction and internal fixation, treatment of
diaphyseal forearm fractures was problematic. Plates *solved* the problem of
diaphyseal forearm fractures. Already in 1972, orthopaedic surgeons reported
rates of union greater than 95% with ASIF compression plates[3, 4]. Multiple
studies show predictable rates of healing and low complication rate of ORIF for
both bones forearm fractures[3, 5-14]. Only severe compound fractures, grade
IIIB and C are associated with unsatisfactory outcome[7]. Open reduction and
internal fixation is the evidence-based standard of care[1-3, 5-14].
It is a notable achievement of orthopaedic surgery that a formerly problematic
injury has been transformed into one that we can repair so that the patients
has very little objective impairment. It is a true success story of
orthopaedics[2].
In this context, it is notable that disability after this injury does NOT
correlate with impairment, at least according to Droll and coleagues[1]. They
concluded that perceived disability as measured with the DASH and SF-36
questionnaires is determined by pain more than by objective physical
impairment. If this finding can be confirmed in Dutch patients with even
longer follow-up, it will establish definitively the substantial and largely
unexplained gap between objective impairment and subjective disability[15].
This finding would establish that even the best orthopaedic treatments are not
sufficient to optimize health and well-being and a more comprehensive
biopsychosocial model of illness *even obvious illnesses such as fractures* is
merited and worthwhile.
Study objective
The aim of this project is to assess objective impairment and arm-specific
disability (DASH scores) in long-term follow-up of patients with diaphyseal
fractures of both bones of the forearm treated with open reduction and plate
and screw fixation, and to determine the correlation between impairment and
disability.
* Primary Study Question: Does depression as measured by the CESD account for a
greater portion of the variability in DASH scores than forearm arc of motion?
* Secondary Study Questions:
What are the predictors of DASH scores from among the following:
depression, motion and radiographic measures?
Hypothesis: We expect that subjective factors *i.e. pain and depression as
measured by CESD-NL and PCS* account for a greater portion in the variability
of DASH scores than objective measures such as forearm motion and radiographic
outcome.
Study design
* Study Subjects, specimens or materials
We will collect data from the AO trauma database and clinical charts of all
patients that have been treated with open reduction and internal fixation for
fractures of both bones of the forearm between 1974 and 1998 to allow for at
least 10 years follow-up. .
* Effect and outcome variables
Classification and description of fractures of both bones of the forearm and
radiological quantification of distal radial intra-articular incongruity if
present (mm).
Arm function as quantified by the following scoring systems:
* The Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)[18, 19]
is scaled from 0 *100 point with higher scores indicating worse upper
extremity-specific disability.
Radiographic follow up with standard forearm projections, Anterior-posterior
(AP), Lateral (LAT) and Oblique views (OBL). Standard measurements for radial
tilt, volar inclination and ulnar variance will be used.
* Methods for taking measurements
Informed consent will be obtained from all patients prior to enrollment. Only
patients older than 18 years will be included.
Demographic and injury related data will be obtained from the AO-AMC trauma
database and the patients* clinical charts.
The DASH questionnaire will be filled out by the patients at their long-term
follow up appointment. Range of motion in the radio-ulnar deviation,
pronation-supination and flexion-extension arcs will be measured with a hand
held goniometer. Lastly, objective evaluation for grip strength (max of 3
attempts with dynamometer 3rd station, elbow at 90 and neutral) will be
performed by authors not involved in the patient care.
Study burden and risks
Not applicable
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
We will collect data from the AO trauma database and clinical charts of all patients that have been treated with open reduction and internal fixation for fractures of both bones of the forearm between 1974 and 1998 to allow for at least 10 years follow-up
Exclusion criteria
Patients younger than 18 years.
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 | NL25786.018.08 |