Ninety percent of Metacarpal fractures (MCFs) (neck, shaft and intra-articular fractures) are treated non-operatively. Generally, non-operative treatment is defined as immobilization by a forearm cast. Recently it was shown that patients with 5th…
ID
Source
Brief title
Condition
- Other condition
- Fractures
Synonym
Health condition
Werkverzuim
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Function, pain and disability expressed as change in Michigan Hand
Questionnaire Score (MHQ) during the first three months. MHQ will be assessed
at baseline/randomization, one week, three weeks, five weeks and twelve weeks
after randomization. The MHQ is a validated tool for assessing functional
outcome in patients with complaints of the hand. The MHQ is a questionnaire
divided in six subscales; overall hand function, activities of daily living
(ADLs), pain, work performance, aesthetics and patient satisfaction with hand
function. Each subscale has a formula to calculate a score from 0 (severe
disability) to 100 (no disability). The final score is a summation of the six
individual item-scores divided by six and ranges from 0 (severe disability) to
100 (no disability).
Secondary outcome
- Michigan Hand Questionnaire Score measured at twelve months.
- Disability, expressed as change on Patient Specific Functional and pain
Scales (PSFS) during the first three months. PFSF data will be gathered at
baseline/randomization, one week, three weeks, five weeks and twelve weeks, six
months and twelve months after randomization10. The PSFS is a list of 3-5
self-chosen activities, scored from 0 (difficult to perform activity) to 10 (no
difficulty to perform activity). The final score goes from 0 (severe
difficulty) tot 10 (no difficulty) and is a summation of the activity scores
divided by the number of activities.
- Health literacy; the ability of an individual to access, understand, and use
health-related information and services to make appropriate health decisions,
with the Newest Vital Sign- Dutch langue version (NVS-D)11. The NVS-D is a
6-item questionnaire where a score of 4 or more right answers distinguish
individuals with adequate versus inadequate health literacy. The NVS-D will be
measured once, during an out-patient clinic appointment, preferably after
randomization.
- Overall patient satisfaction (of the injury of the hand), on Visual Analogue
Satisfaction Scale, scored from 0 (very dissatisfied) to 10 (completely
satisfied), measured at at baseline/randomization, three weeks and twelve
weeks, six months and twelve months after randomization
- Overall patient satisfaction (of the injury of the hand), on a 5 point scale
from -2 (very dissatisfied) to +2 (completely satisfied) measured at
baseline/randomization, three weeks and twelve weeks, six months and twelve
months after randomization
- Patient satisfaction about improvement of function of the finger between the
operation and three months with the Visual Analogue Satisfaction Scale, scored
from 0 (very dissatisfied) -to 10 (completely satisfied), measured at three
months and patient satisfaction about improvement of function of the finger
between three months and twelve months with the Visual Analogue Satisfaction
Scale, scored from 0 (very dissatisfied) to 10 (completely satisfied),
measured at twelve months.
- Patient satisfaction about improvement of function of the finger between
operation and three months on a 5 point scale from -2 (no improvement) to +2
(completely improved), measured at three months, and patient satisfaction of
improvement of function of the finger between three and twelve months on a 5
point scale from -2 (no improvement) to +2 (completely improved), measured at
twelve months.
- Patient satisfaction about improvement of pain of the finger between
operation and three months on a 5 point scale from -2 (no improvement) to +2
(completely improved), measured at three months and patient satisfaction of
improvement of pain of the finger between three and twelve months on a 5 point
scale from -2 (no improvement) to +2 (completely improved), measured at twelve
months.
- Patient satisfaction on improvement of disability of the finger between
operation and three months on a 5 point scale from -2 (no improvement) to- +2
(completely improved), measured at three months and patient satisfaction on
improvement of disability of the finger between three and twelve months on a 5
point scale from -2 (no improvement) to +2 (completely improved), measured at
twelve months.
- Patient satisfaction on aesthetics of the finger over the last three months
on a 5 point scale from -2 (no improvement) to +2 (completely improved),
measured at three months and patient satisfaction on aesthetics of the finger
between three and twelve months on a 5 point scale from -2 (no improvement) to
+2 (completely improved), measured at twelve months.
- Patient satisfaction on work performance over the last three months on a 5
point scale from -2 (no improvement) to +2 (completely improved), measured at
three months and patient satisfaction on work performance between three and
twelve months on a 5 point scale from -2 (no improvement) to +2 (completely
improved), measured at twelve months.
- Overall satisfaction of the finger over the last 3 months on a 5 point scale
from -2 (no improvement) to +2 (completely improved), measured at three months
and overall satisfaction of the finger between three and twelve months on a 5
point scale from -2 (no improvement) to +2 (completely improved), measured at
twelve months.
- Pain as indicated on a Visual Analogue Scale (VAS), where 0 implies no pain
and 10 the worst possible pain, measured at baseline/randomization, three weeks
and twelve weeks, six months and twelve months after randomization
- Patient-expectation; Pre-consultation expectation of the patient on recovery
and post-consultation achievement of this expectation. At randomization
patients will be asked what they expect to achieve in degree of improvement and
restriction at a five-point scale; 1. No improvement, full restriction; 2.
Slight improvement, serious restriction; 3. Moderate improvement, moderate
restriction; 4. Substantial improvement, slight restriction; 5. Complete
improvement, no restriction.
At the last outpatient clinic visit (in general at twelve weeks after
randomization) and at 12 months after randomization, patients will be asked to
answer the same question with respect to their current health status.
Achievement of expectation is expressed as the difference between their answer
of the pre- and post-consultation questions.
- Total active motion (TAM) = Active Range Of Motion of the
metacarpal-phalangeal joint, the proximal interphalangeal joint and the distal
interphalangeal joint minus any extension deficits12. TAM is measured at
randomization, three weeks and twelve weeks after randomization.
- Range of motion (ROM) of the wrist measured on both sides with a handheld
goniometer. ROM includes pronation and supination, ulnar and radial deviation
and palmar and dorsal flexion of the wrist. ROM is measured at randomization,
three weeks and twelve weeks after randomization.
- Health care costs, productivity losses and out-of-pocket expenses with the
adapted Dutch iMTA Medical Consumption Questionnaire and iMTA Productivity Cost
Questionnaire (see economic evaluation below), measured at three weeks, twelve
weeks and six and twelve months after randomization.
- Measurement of health status with the EQ-5D-5L at randomization/baseline,
three weeks and twelve weeks and six and twelve months after randomization.
This questionnaire consists of 5 items, measuring (at 5-point scales) whether
patients experience problems, and if so, to what extent with regard to
mobility, self-care, daily activities, pain/complaints, and mood.
- Health utility and quality adjusted life-years (see economic evaluation
below).
- Complications as; stiffness, re-operation, re-dislocation.
Background summary
The majority of metacarpal fractures (MCFs) (neck, shaft and intra-articular
fractures) are treated nonoperatively. Generally, nonoperative MCFs are
immobilized by a forearm cast, following the current guideline. (The thumb (MCF
1) is functionally more complex which requires tailor made treatment and
therefore non comparable to MCF 2-5.) Plaster immobilization often results in
stiffness and dysfunction of the metacarpal and proximal interphalangeal joints
and wrist, often requiring hand therapy. Recently it was shown that patients
with 5th neck MCFs had less stiffness and earlier return to work with
concomitant lower costs when functionally treated. Due to these results,
functional treatment of 5th neck MCF is recommended by the Dutch hand fracture
guideline committee. Unfortunately, qualitatively focused studies describing
functional treatment of MCFs 2-4 and 5th MCFs (other than neck fractures) are
lacking. Therefore, we want to conduct a randomized study including these type
of fractures. Functional outcome and cost-effectiveness will be studied
comparing functional treatment by a Lucerne cast with immobilization by a
forearm cast.
Study objective
Ninety percent of Metacarpal fractures (MCFs) (neck, shaft and intra-articular
fractures) are treated non-operatively. Generally, non-operative treatment is
defined as immobilization by a forearm cast. Recently it was shown that
patients with 5th neck MCFs had less stiffness and earlier return to work with
concomitant lower costs when functionally treated. Qualitatively focused
studies describing functional treatment of MCFs 2-4 and 5th MCFs (other than
neck fractures) are lacking. Therefore, to demonstrate that functional
treatment is also superior in these types of metacarpal fractures, our
objective is to compare the functional outcome and cost-effectiveness of a
functional Lucerne cast with immobilization by a conventional forearm cast in
adult patients.
Study design
Multicentre randomized clinical superiority trial. Study inclusion period 1.5
years.
Intervention
-USUAL/STANDARD CARE
The Dutch hand fracture guideline committee recommends to immobilize patients
for 3-5 weeks in a forearm cast resulting in stiffness of wrist and fingers
after cast removal. Standard treatment by forearm cast consists of:
1. Immobilization by a forearm cast constructed at the emergency department(ED)
2. Replacement of this ED-cast by a plastic, customized forearm cast within 1
week at the cast-room.
3. Removal of this plastic cast after 3 weeks (4 weeks after trauma)
-INTERVENTION
Functional treatment of wrist and fingers by a Lucerne cast. Functional
treatment will lead to less stiffness. The principle of the Lucerne cast is
securing the MCP joints in intrinsic position but allowing movement of the
proximal interphalangeal joints and the wrist joint. Standard functional
treatment by a Lucerne cast consists of:
1. Immobilization by a forearm cast constructed at the ED
2. Replacement of this ED-cast by a plastic, customized Lucerne cast within 1
week at the cast-room.
3. Removal of this Lucerne cast after 3 weeks (4 weeks after trauma).
Study burden and risks
Both treatment modalities are standard care. The treatment of choice is
currently based on surgeon*s preference. Out-patient clinic visits are at one
and four weeks and at three months. All visits are standard care in case of
conservative treatment of a metacarpal fracture (if the emergency department
visit occurs during evening or night shifts and the patient is randomized in
the intervention group, the patient needs to return to the cast room for a
custom made Lucerne cast the next day). During the visits patients will be
asked if there are any complaints and/or complications. Physical examination
like assessment of the range of motion of the hand and wrist will be executed.
Additional to standard care, questionnaires are received at one, two, four, six
weeks and at three, six and twelve months. Questionnaires can be filled out at
home at all times, no additional out-patient clinic visits are necessary for
the questionnaires. Patients are asked to fill out MHQ, PSFS, EQ-5D-5L,the
Visual Analogue Pain Scale, Visual Analogue Satisfaction scale and 5-point
satisfaction scores. Additionally, a questionnaire on any use of health care,
health related expenses and absence from work will be administered and patients
will be asked to fill out the NVS-D once. Subjects could experience mild
discomfort during physical examination and testing, but this will be no
different than physical examination during routine follow-up. The burden
experienced regarding time spent on questionnaires is difficult to estimate but
will most likely not exceed two and a half hours in the total follow-up
duration of this study (1 year).
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
a. Population (base)
- Adult patients with metacarpal fractures (MCFs) 2-4 and 5th MCFs (other than
neck fractures), requiring nonoperative treatment. The fracture needs to be
diagnosed on a radiograph at the emergency department.b. Inclusion criteria
- Patients >=18 years
- Single MCF 2-4 (neck, shaft or intra-articular)and 5th MCFs (other than neck
fractures)
Exclusion criteria
- Operation indication; functional restrictions due to shortening, rotation or
angulation
- Volar angulation of the 5th ray >= 30
- Volar angulation of the 4th ray >=30
- Volar angulation of the 3th and 2nd ray >=20
- Rotation disorders; clinical functional restriction such as scissoring
fingers
- Metacarpal shortening by segmental bone loss or < 50% bone to bone contact
- Irreducible dislocations
- Operative treatment
- Fifth metacarpal neck fractures
- Multiple metacarpal fractures in one hand
- Metacarpal fracture of the first ray
- Operative treatment
- Absence of one of the following radiographs: Posterior-Anterior, 3/4-shot.
- Patients with impaired hand function prior to injury due to
arthrosis/neurological disorders of the upper limb
- Multiple trauma patients (Injury Severity Score (ISS) >=16)
- Other injuries in the ipsilateral extremity
- Insufficient comprehension of the Dutch language to understand a
rehabilitation program and other treatment information as judged by the
attending physician
- Patient suffering from disorders of bone metabolism other than osteoporosis
(i.e. Paget*s disease, renal osteodystrophy, osteomalacia)
- Patients suffering from connective tissue disease or (joint)
hyper-flexibility disorders such as Marfan*s, Ehler Danlos or other related
disorders
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Nederlands trial register |
| CCMO | NL67401.100.19 |