Primary objective:The primary objective of this observational study is evaluate the use of a plasteraid splint to gain and hold the desired 90-0-0 protective position in the conservative treatment of patients with metacarpal fractures of the second…
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the DASH-DLV (Disabilities of the Arm, Shoulder and
Hand-Dutch Language Version), a validated Dutch translation (Veehof 2002) of
the original DASH (Beaton 2001) to evaluate disabilities and symptoms as a
result of the metacarpal fracture treatment and to evaluate the ability of the
Plasteraid splint to hold the desired 90-0-0 position. This DASH-DLV scoring
form is filled out by the patients at t=0,1,4 and 8 weeks.
Secondary outcome
The following items will be secondary parameters/endpoints:
Full active range of motion (ROM) of the MCP joint 8 weeks following removal of
the splint.
The need for physiotherapy and time to return to hobby or profession (at t=8
weeks) and loss to follow-up.
Background summary
The optimal conservative treatment of closed metacarpal fractures without
severe rotation or ulnar / radial angulation remains subject of debate.
Concerning the fifth metacarpal fracture no randomized controlled trial showed
Level I evidence for the optimal type of conservative treatment (Poolman 2005).
Fractures of the second to fourth metacarpal as well as the so called boxer's
fracture (subcapital fracture of the fifth metacarpal) are traditionally
immobilized with application of plaster-of-paris in the 'protective position',
with the metacarpophalangeal joints flexed in 90 degrees while holding the
interphalangeal joints in (near-) extension. This position of 90-0-0 has long
been considered as the golden standard in the conservative treatment of
eligible metacarpal fractures.
Though several author's have reported good functional and anatomical results
when metacarpal fractures were directly treated functional (Braakman 1998,
Breddam 1995 , Konradsen 1990, Kuokkanen 1999, Statius Muller 2003), most
centers still protocollary apply the 90-0-0 plaster-of-paris cast
immobilization for a period of three to four weeks.
Most of the patients with metacarpal fractures initially present themselves at
the emergency wards where decision is made according to local customs and
protocols for an operative or conservative treatment strategy depending on
factors as shortening of the bone, angulation (dorsovolar and ulnoradial),
associated injury, rotation and wounds,.
If a conservative treatment is chosen, applying the plaster-of-paris cast in
the desired protective position of 90-0-0 requires preferably a low-stress
environment, patient cooperation and, most important, the experience of the
personnel applying this specific plaster. Especially during night and weekends
these factors are not infrequently suboptimal. Patients tend to cooperate badly
during splinting as they might be intoxicated and acquired their fracture in a
fight. The need for fracture reduction could further compromise the quality of
the applied position of the plaster cast.
In most hospitals, patients with an aforementioned plaster-of-paris cast will
have their follow-up one week after initial treatment. A radiological
evaluation of the position of the fracture as well as the 'correctness' of the
90-0-0 position is reviewed in the outpatient clinic.
Inadequate positioning of the hand with plaster-of-paris remains an occurrence
with potential consequences. First, there may be a need for reapplying the
plaster by specialized personnel, which is time-consuming and should not be
necessary. It puts a strain on both hospital resources (time) and patient
(discomfort, pain). Second, the reapplication of the 90-0-0 plaster on an
initially adequately reduced unstable metacarpal fracture might generate the
secondary need for operative intervention. Third, if during the immobilization
period a suboptimal fixed position of the hand with plaster-of-paris- for
external reasons- is not corrected or seen by specialized personnel this might
result in a longer period of revalidation, the need for physiotherapy and a
prolonged inability to return to hobby or work with subsequent socio-economic
consequences.
By immobilizing eligible metacarpal (including boxer's) fractures using a
splint that has an anatomically preshaped position of 90-0-0 (a *plasteraid*
splint) as alternative to current practice, the quality of the initial fixation
might reduce short-term mentioned effects of initial suboptimal fixation.
We are not aware of any reported prospective trial treating metacarpal
fractures with such a specific preshaped splint to gain the protective
position, although good results with other supportive measures such as
compressive metacarpal gloves (McMahon 1994) or functional (metacarpal) braces
around the wrist and hand (Hansen 1998, Harding 2001, Konradsen 1990, Sorensen
1993, Viegas 1987) have been reported. However, other studies reported skin
necrosis due to pressure (Poolman 2005).
This pilot study will be conducted to evaluate the effectiveness of the
plasterade splint as well as potential adverse effects. Depending on these
initial study results a randomized trial will be performed to compare
traditional treatment with using the plasteraid splint.
Study objective
Primary objective:
The primary objective of this observational study is evaluate the use of a
plasteraid splint to gain and hold the desired 90-0-0 protective position in
the conservative treatment of patients with metacarpal fractures of the second
to fifth metacarpal. For this, functional results (measured using the DASH
scoring form) will be registered. We want to evaluate the effectiveness and
applicability of the plasteraid splint as well as potential adverse effects of
the usage of such a splint.
Secondary objective:
The study is meant to lead to the development of the most optimal type of
metacarpal splint.
Study design
The study will be an observational study, whereas 20 consecutive eligible
patients (cumulative included in the five participating hospitals) with a
traumatic metacarpal fracture of the second to fifth metacarpal will be treated
using a plasteraid splint. The duration of the study will be twelve weeks.
Study burden and risks
The application of the splint is meant to gain and hold the position of
protection as pursued with conventional casting. Therefore it is an
instrument/tool to optimize the quality of current treatment. The use of a
plasteraid splint might lead to adverse effects such as sub-splint
transpiration and pressure sores if the splint size/shape is not optimal for
the patients* anatomy treated
veerstraat 18-3
1075sv amsterdam
Nederland
veerstraat 18-3
1075sv amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients with closed fractures of the metacarpal II-V (including boxer's fracture) that are not older than 72 hours, with or without the need for fracture reduction. Patients have to be older than 18 years old and without ipsilateral or associated injury (i.e. more fractures of the same hand).
Exclusion criteria
Open or pathological fractures, ipsilateral hand fractures, severe rotation deformity or ulnar/radial angulation, severe bone shortening, associated injury and the probability of loss to follow-up. A primary indication for operation according to local hospital customs and/or protocols is an exclusion criteria. Language barriers and/or intoxication which can*t guarantee adequate follow-up or understanding of the study and/or informed consent.
Design
Recruitment
Medical products/devices used
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
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CCMO | NL21611.100.08 |